Trial Outcomes & Findings for A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets (NCT NCT02063854)
NCT ID: NCT02063854
Last Updated: 2017-02-23
Results Overview
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
871 participants
Primary outcome timeframe
Baseline and End of Study (up to Month 12)
Results posted on
2017-02-23
Participant Flow
Participants took part in the study at 67 investigative sites in Japan from 21 February 2014 to 19 November 2015.
Participants with a diagnosis of involutional osteoporosis were randomized at a ratio of 3:1:3:1:1:3:1 into 1 of 7 treatment groups: once-daily NE-58095 2.5 mg immediate release (IR) or once-monthly NE-58095 25 mg or 37.5 mg delayed release (DR) on awakening, after breakfast or 30 minutes following breakfast.
Participant milestones
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
199
|
66
|
206
|
68
|
65
|
201
|
66
|
|
Overall Study
Full Analysis Set: Received Study Drug
|
199
|
66
|
206
|
68
|
65
|
200
|
66
|
|
Overall Study
COMPLETED
|
178
|
54
|
176
|
58
|
54
|
170
|
60
|
|
Overall Study
NOT COMPLETED
|
21
|
12
|
30
|
10
|
11
|
31
|
6
|
Reasons for withdrawal
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
13
|
10
|
13
|
8
|
7
|
18
|
4
|
|
Overall Study
Major Protocol Deviation
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Voluntary Withdrawal
|
2
|
0
|
8
|
1
|
3
|
6
|
1
|
|
Overall Study
Surgical Dental Work Performed/Planned
|
5
|
2
|
6
|
1
|
1
|
6
|
1
|
|
Overall Study
Reason Not Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Did Not Receive Study Drug
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Baseline characteristics by cohort
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly on Awakening
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=201 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
Total
n=871 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7.32 • n=99 Participants
|
69.0 years
STANDARD_DEVIATION 8.18 • n=107 Participants
|
68.2 years
STANDARD_DEVIATION 7.68 • n=206 Participants
|
68.4 years
STANDARD_DEVIATION 7.24 • n=7 Participants
|
69.0 years
STANDARD_DEVIATION 6.98 • n=31 Participants
|
69.6 years
STANDARD_DEVIATION 7.19 • n=30 Participants
|
69.8 years
STANDARD_DEVIATION 7.87 • n=3 Participants
|
68.9 years
STANDARD_DEVIATION 7.45 • n=6 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
198 Participants
n=30 Participants
|
63 Participants
n=3 Participants
|
847 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
|
Region of Enrollment
Japan
|
199 participants
n=99 Participants
|
66 participants
n=107 Participants
|
206 participants
n=206 Participants
|
68 participants
n=7 Participants
|
65 participants
n=31 Participants
|
201 participants
n=30 Participants
|
66 participants
n=3 Participants
|
871 participants
n=6 Participants
|
|
Height
|
152.1 cm
STANDARD_DEVIATION 6.59 • n=99 Participants
|
151.0 cm
STANDARD_DEVIATION 6.64 • n=107 Participants
|
151.9 cm
STANDARD_DEVIATION 6.11 • n=206 Participants
|
152.5 cm
STANDARD_DEVIATION 5.49 • n=7 Participants
|
153.5 cm
STANDARD_DEVIATION 5.13 • n=31 Participants
|
151.3 cm
STANDARD_DEVIATION 5.20 • n=30 Participants
|
151.9 cm
STANDARD_DEVIATION 6.47 • n=3 Participants
|
151.9 cm
STANDARD_DEVIATION 6.00 • n=6 Participants
|
|
Weight
|
50.52 kg
STANDARD_DEVIATION 7.975 • n=99 Participants
|
49.98 kg
STANDARD_DEVIATION 6.720 • n=107 Participants
|
50.20 kg
STANDARD_DEVIATION 7.231 • n=206 Participants
|
50.97 kg
STANDARD_DEVIATION 8.736 • n=7 Participants
|
51.26 kg
STANDARD_DEVIATION 7.473 • n=31 Participants
|
50.36 kg
STANDARD_DEVIATION 7.383 • n=30 Participants
|
50.51 kg
STANDARD_DEVIATION 7.427 • n=3 Participants
|
50.46 kg
STANDARD_DEVIATION 7.544 • n=6 Participants
|
|
Body Mass Index (BMI)
|
21.82 kg/m^2
STANDARD_DEVIATION 3.009 • n=99 Participants
|
21.93 kg/m^2
STANDARD_DEVIATION 2.830 • n=107 Participants
|
21.75 kg/m^2
STANDARD_DEVIATION 2.926 • n=206 Participants
|
21.97 kg/m^2
STANDARD_DEVIATION 3.875 • n=7 Participants
|
21.79 kg/m^2
STANDARD_DEVIATION 3.289 • n=31 Participants
|
22.00 kg/m^2
STANDARD_DEVIATION 3.105 • n=30 Participants
|
21.90 kg/m^2
STANDARD_DEVIATION 3.071 • n=3 Participants
|
21.87 kg/m^2
STANDARD_DEVIATION 3.092 • n=6 Participants
|
|
Smoking Classification
Never smoked
|
167 participants
n=99 Participants
|
55 participants
n=107 Participants
|
178 participants
n=206 Participants
|
53 participants
n=7 Participants
|
54 participants
n=31 Participants
|
168 participants
n=30 Participants
|
58 participants
n=3 Participants
|
733 participants
n=6 Participants
|
|
Smoking Classification
Current smoker
|
10 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
7 participants
n=30 Participants
|
3 participants
n=3 Participants
|
41 participants
n=6 Participants
|
|
Smoking Classification
Ex-smoker
|
22 participants
n=99 Participants
|
7 participants
n=107 Participants
|
17 participants
n=206 Participants
|
12 participants
n=7 Participants
|
8 participants
n=31 Participants
|
26 participants
n=30 Participants
|
5 participants
n=3 Participants
|
97 participants
n=6 Participants
|
|
Menopausal Status
Natural Menopause
|
170 participants
n=99 Participants
|
58 participants
n=107 Participants
|
179 participants
n=206 Participants
|
60 participants
n=7 Participants
|
53 participants
n=31 Participants
|
180 participants
n=30 Participants
|
59 participants
n=3 Participants
|
759 participants
n=6 Participants
|
|
Menopausal Status
Artificial Menopause
|
20 participants
n=99 Participants
|
6 participants
n=107 Participants
|
24 participants
n=206 Participants
|
6 participants
n=7 Participants
|
10 participants
n=31 Participants
|
18 participants
n=30 Participants
|
4 participants
n=3 Participants
|
88 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
Min - ≤5 years
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
4 participants
n=7 Participants
|
3 participants
n=31 Participants
|
4 participants
n=30 Participants
|
2 participants
n=3 Participants
|
31 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
6 - ≤10 years
|
23 participants
n=99 Participants
|
1 participants
n=107 Participants
|
28 participants
n=206 Participants
|
4 participants
n=7 Participants
|
8 participants
n=31 Participants
|
22 participants
n=30 Participants
|
6 participants
n=3 Participants
|
92 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
11 - ≤20 years
|
59 participants
n=99 Participants
|
21 participants
n=107 Participants
|
71 participants
n=206 Participants
|
29 participants
n=7 Participants
|
20 participants
n=31 Participants
|
61 participants
n=30 Participants
|
20 participants
n=3 Participants
|
281 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
21 - ≤30 years
|
55 participants
n=99 Participants
|
19 participants
n=107 Participants
|
42 participants
n=206 Participants
|
12 participants
n=7 Participants
|
19 participants
n=31 Participants
|
58 participants
n=30 Participants
|
19 participants
n=3 Participants
|
224 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
≥31 years
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
7 participants
n=7 Participants
|
4 participants
n=31 Participants
|
17 participants
n=30 Participants
|
4 participants
n=3 Participants
|
58 participants
n=6 Participants
|
|
Number of Years After Menopause, Categorical
Unknown, But >2 years
|
38 participants
n=99 Participants
|
12 participants
n=107 Participants
|
44 participants
n=206 Participants
|
10 participants
n=7 Participants
|
9 participants
n=31 Participants
|
36 participants
n=30 Participants
|
12 participants
n=3 Participants
|
161 participants
n=6 Participants
|
|
Number of Years After Menopause
|
18.6 years
STANDARD_DEVIATION 7.81 • n=99 Participants
|
20.2 years
STANDARD_DEVIATION 8.72 • n=107 Participants
|
17.2 years
STANDARD_DEVIATION 8.44 • n=206 Participants
|
18.3 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
19.2 years
STANDARD_DEVIATION 8.36 • n=31 Participants
|
19.5 years
STANDARD_DEVIATION 8.41 • n=30 Participants
|
20.1 years
STANDARD_DEVIATION 7.84 • n=3 Participants
|
18.7 years
STANDARD_DEVIATION 8.28 • n=6 Participants
|
|
History of Bisphosphonate Administration
Yes
|
19 participants
n=99 Participants
|
6 participants
n=107 Participants
|
24 participants
n=206 Participants
|
8 participants
n=7 Participants
|
9 participants
n=31 Participants
|
26 participants
n=30 Participants
|
6 participants
n=3 Participants
|
98 participants
n=6 Participants
|
|
History of Bisphosphonate Administration
No
|
180 participants
n=99 Participants
|
60 participants
n=107 Participants
|
182 participants
n=206 Participants
|
60 participants
n=7 Participants
|
56 participants
n=31 Participants
|
175 participants
n=30 Participants
|
60 participants
n=3 Participants
|
773 participants
n=6 Participants
|
|
Timing of Initial Delayed Release (DR) Tablet Administration on Awakening
Less than 30 Minutes before Breakfast
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
1 participants
n=6 Participants
|
|
Timing of Initial Delayed Release (DR) Tablet Administration on Awakening
0.5 to 1.5 Hours before Breakfast
|
165 participants
n=99 Participants
|
56 participants
n=107 Participants
|
167 participants
n=206 Participants
|
52 participants
n=7 Participants
|
53 participants
n=31 Participants
|
164 participants
n=30 Participants
|
50 participants
n=3 Participants
|
707 participants
n=6 Participants
|
|
Timing of Initial Delayed Release (DR) Tablet Administration on Awakening
1.5 to 2.5 Hours before Breakfast
|
29 participants
n=99 Participants
|
8 participants
n=107 Participants
|
35 participants
n=206 Participants
|
13 participants
n=7 Participants
|
8 participants
n=31 Participants
|
27 participants
n=30 Participants
|
15 participants
n=3 Participants
|
135 participants
n=6 Participants
|
|
Timing of Initial Delayed Release (DR) Tablet Administration on Awakening
2.5 to 4 Hours before Breakfast
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
3 participants
n=7 Participants
|
4 participants
n=31 Participants
|
8 participants
n=30 Participants
|
1 participants
n=3 Participants
|
27 participants
n=6 Participants
|
|
Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical
Min - ≤0.707 g/cm^2
|
167 participants
n=99 Participants
|
46 participants
n=107 Participants
|
176 participants
n=206 Participants
|
54 participants
n=7 Participants
|
52 participants
n=31 Participants
|
158 participants
n=30 Participants
|
49 participants
n=3 Participants
|
702 participants
n=6 Participants
|
|
Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical
0.708 (70%YAM) - ≤0.808 g/cm^2
|
24 participants
n=99 Participants
|
13 participants
n=107 Participants
|
21 participants
n=206 Participants
|
11 participants
n=7 Participants
|
10 participants
n=31 Participants
|
28 participants
n=30 Participants
|
11 participants
n=3 Participants
|
118 participants
n=6 Participants
|
|
Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical
0.809 (80%YAM) g/cm^2 - ≤Max
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
9 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
14 participants
n=30 Participants
|
6 participants
n=3 Participants
|
50 participants
n=6 Participants
|
|
L2-L4 (BMD)
|
0.6553 g/cm^2
STANDARD_DEVIATION 0.09060 • n=99 Participants
|
0.6690 g/cm^2
STANDARD_DEVIATION 0.11746 • n=107 Participants
|
0.6477 g/cm^2
STANDARD_DEVIATION 0.08037 • n=206 Participants
|
0.6633 g/cm^2
STANDARD_DEVIATION 0.08766 • n=7 Participants
|
0.6448 g/cm^2
STANDARD_DEVIATION 0.08909 • n=31 Participants
|
0.6589 g/cm^2
STANDARD_DEVIATION 0.09893 • n=30 Participants
|
0.6714 g/cm^2
STANDARD_DEVIATION 0.09999 • n=3 Participants
|
0.6564 g/cm^2
STANDARD_DEVIATION 0.09303 • n=6 Participants
|
|
L2-L4 BMD T-score, Categorical
Min - ≤-2.500
|
169 participants
n=99 Participants
|
47 participants
n=107 Participants
|
177 participants
n=206 Participants
|
54 participants
n=7 Participants
|
53 participants
n=31 Participants
|
160 participants
n=30 Participants
|
51 participants
n=3 Participants
|
711 participants
n=6 Participants
|
|
L2-L4 BMD T-score, Categorical
-2.499 - ≤-1.000
|
28 participants
n=99 Participants
|
16 participants
n=107 Participants
|
26 participants
n=206 Participants
|
12 participants
n=7 Participants
|
12 participants
n=31 Participants
|
36 participants
n=30 Participants
|
12 participants
n=3 Participants
|
142 participants
n=6 Participants
|
|
L2-L4 BMD T-score, Categorical
-0.999 - ≤Max
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
2 participants
n=7 Participants
|
0 participants
n=31 Participants
|
4 participants
n=30 Participants
|
3 participants
n=3 Participants
|
17 participants
n=6 Participants
|
|
L2-L4 BMD T-score
|
-2.9889 score on a scale
STANDARD_DEVIATION 0.76130 • n=99 Participants
|
-2.8738 score on a scale
STANDARD_DEVIATION 0.98709 • n=107 Participants
|
-3.0532 score on a scale
STANDARD_DEVIATION 0.67537 • n=206 Participants
|
-2.9219 score on a scale
STANDARD_DEVIATION 0.73670 • n=7 Participants
|
-3.0773 score on a scale
STANDARD_DEVIATION 0.74863 • n=31 Participants
|
-2.9587 score on a scale
STANDARD_DEVIATION 0.83135 • n=30 Participants
|
-2.8536 score on a scale
STANDARD_DEVIATION 0.84030 • n=3 Participants
|
-2.9796 score on a scale
STANDARD_DEVIATION 0.78178 • n=6 Participants
|
|
Total Proximal Femur BMD
|
0.6553 g/cm^2
STANDARD_DEVIATION 0.08997 • n=99 Participants
|
0.6573 g/cm^2
STANDARD_DEVIATION 0.09537 • n=107 Participants
|
0.6452 g/cm^2
STANDARD_DEVIATION 0.08490 • n=206 Participants
|
0.6580 g/cm^2
STANDARD_DEVIATION 0.07982 • n=7 Participants
|
0.6486 g/cm^2
STANDARD_DEVIATION 0.06973 • n=31 Participants
|
0.6652 g/cm^2
STANDARD_DEVIATION 0.08465 • n=30 Participants
|
0.6520 g/cm^2
STANDARD_DEVIATION 0.07289 • n=3 Participants
|
0.6548 g/cm^2
STANDARD_DEVIATION 0.08464 • n=6 Participants
|
|
Total Proximal Femur BMD T-score
|
-2.1972 score on a scale
STANDARD_DEVIATION 0.89971 • n=99 Participants
|
-2.1770 score on a scale
STANDARD_DEVIATION 0.95369 • n=107 Participants
|
-2.2982 score on a scale
STANDARD_DEVIATION 0.84903 • n=206 Participants
|
-2.1699 score on a scale
STANDARD_DEVIATION 0.79822 • n=7 Participants
|
-2.2642 score on a scale
STANDARD_DEVIATION 0.69731 • n=31 Participants
|
-2.0978 score on a scale
STANDARD_DEVIATION 0.84652 • n=30 Participants
|
-2.2305 score on a scale
STANDARD_DEVIATION 0.72892 • n=3 Participants
|
-2.2021 score on a scale
STANDARD_DEVIATION 0.84645 • n=6 Participants
|
|
Trochanter BMD
|
0.4938 g/cm^2
STANDARD_DEVIATION 0.07793 • n=99 Participants
|
0.4954 g/cm^2
STANDARD_DEVIATION 0.06803 • n=107 Participants
|
0.4844 g/cm^2
STANDARD_DEVIATION 0.06610 • n=206 Participants
|
0.4932 g/cm^2
STANDARD_DEVIATION 0.07164 • n=7 Participants
|
0.4879 g/cm^2
STANDARD_DEVIATION 0.05653 • n=31 Participants
|
0.5009 g/cm^2
STANDARD_DEVIATION 0.06626 • n=30 Participants
|
0.4900 g/cm^2
STANDARD_DEVIATION 0.06824 • n=3 Participants
|
0.4925 g/cm^2
STANDARD_DEVIATION 0.06914 • n=6 Participants
|
|
Femoral Neck BMD
|
0.5318 g/cm^2
STANDARD_DEVIATION 0.07695 • n=99 Participants
|
0.5258 g/cm^2
STANDARD_DEVIATION 0.08147 • n=107 Participants
|
0.5278 g/cm^2
STANDARD_DEVIATION 0.07960 • n=206 Participants
|
0.5348 g/cm^2
STANDARD_DEVIATION 0.07154 • n=7 Participants
|
0.5245 g/cm^2
STANDARD_DEVIATION 0.06293 • n=31 Participants
|
0.5411 g/cm^2
STANDARD_DEVIATION 0.08051 • n=30 Participants
|
0.5373 g/cm^2
STANDARD_DEVIATION 0.07346 • n=3 Participants
|
0.5327 g/cm^2
STANDARD_DEVIATION 0.07712 • n=6 Participants
|
|
Femoral Neck BMD T-score
|
-2.8683 score on a scale
STANDARD_DEVIATION 0.85505 • n=99 Participants
|
-2.9358 score on a scale
STANDARD_DEVIATION 0.90523 • n=107 Participants
|
-2.9135 score on a scale
STANDARD_DEVIATION 0.88448 • n=206 Participants
|
-2.8360 score on a scale
STANDARD_DEVIATION 0.79487 • n=7 Participants
|
-2.9501 score on a scale
STANDARD_DEVIATION 0.69920 • n=31 Participants
|
-2.7652 score on a scale
STANDARD_DEVIATION 0.89454 • n=30 Participants
|
-2.8077 score on a scale
STANDARD_DEVIATION 0.81618 • n=3 Participants
|
-2.8594 score on a scale
STANDARD_DEVIATION 0.85690 • n=6 Participants
|
|
Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus
QDR-4500
|
14 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
5 participants
n=7 Participants
|
6 participants
n=31 Participants
|
12 participants
n=30 Participants
|
6 participants
n=3 Participants
|
62 participants
n=6 Participants
|
|
Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus
Delphi
|
28 participants
n=99 Participants
|
9 participants
n=107 Participants
|
29 participants
n=206 Participants
|
9 participants
n=7 Participants
|
9 participants
n=31 Participants
|
26 participants
n=30 Participants
|
8 participants
n=3 Participants
|
118 participants
n=6 Participants
|
|
Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus
Discovery
|
114 participants
n=99 Participants
|
38 participants
n=107 Participants
|
120 participants
n=206 Participants
|
39 participants
n=7 Participants
|
35 participants
n=31 Participants
|
118 participants
n=30 Participants
|
35 participants
n=3 Participants
|
499 participants
n=6 Participants
|
|
Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus
Explorer
|
43 participants
n=99 Participants
|
14 participants
n=107 Participants
|
43 participants
n=206 Participants
|
15 participants
n=7 Participants
|
15 participants
n=31 Participants
|
45 participants
n=30 Participants
|
17 participants
n=3 Participants
|
192 participants
n=6 Participants
|
|
Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures
0
|
138 participants
n=99 Participants
|
32 participants
n=107 Participants
|
125 participants
n=206 Participants
|
42 participants
n=7 Participants
|
38 participants
n=31 Participants
|
121 participants
n=30 Participants
|
35 participants
n=3 Participants
|
531 participants
n=6 Participants
|
|
Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures
1
|
39 participants
n=99 Participants
|
21 participants
n=107 Participants
|
61 participants
n=206 Participants
|
17 participants
n=7 Participants
|
18 participants
n=31 Participants
|
58 participants
n=30 Participants
|
25 participants
n=3 Participants
|
239 participants
n=6 Participants
|
|
Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures
2
|
12 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
7 participants
n=7 Participants
|
6 participants
n=31 Participants
|
15 participants
n=30 Participants
|
6 participants
n=3 Participants
|
66 participants
n=6 Participants
|
|
Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures
≥3
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
6 participants
n=30 Participants
|
0 participants
n=3 Participants
|
34 participants
n=6 Participants
|
|
Fragility Fracture
Yes
|
86 participants
n=99 Participants
|
37 participants
n=107 Participants
|
91 participants
n=206 Participants
|
32 participants
n=7 Participants
|
31 participants
n=31 Participants
|
104 participants
n=30 Participants
|
36 participants
n=3 Participants
|
417 participants
n=6 Participants
|
|
Fragility Fracture
No
|
113 participants
n=99 Participants
|
29 participants
n=107 Participants
|
115 participants
n=206 Participants
|
36 participants
n=7 Participants
|
34 participants
n=31 Participants
|
97 participants
n=30 Participants
|
30 participants
n=3 Participants
|
454 participants
n=6 Participants
|
|
Primary Osteoporosis Diagnosis Criteria 2012
Fragility Fracture (Vertebrae or Proximal Femur)
|
65 participants
n=99 Participants
|
30 participants
n=107 Participants
|
82 participants
n=206 Participants
|
29 participants
n=7 Participants
|
25 participants
n=31 Participants
|
80 participants
n=30 Participants
|
32 participants
n=3 Participants
|
343 participants
n=6 Participants
|
|
Primary Osteoporosis Diagnosis Criteria 2012
Fragility Fracture (Other and BMD<YAM*80%)
|
21 participants
n=99 Participants
|
7 participants
n=107 Participants
|
9 participants
n=206 Participants
|
3 participants
n=7 Participants
|
6 participants
n=31 Participants
|
24 participants
n=30 Participants
|
4 participants
n=3 Participants
|
74 participants
n=6 Participants
|
|
Primary Osteoporosis Diagnosis Criteria 2012
No Fragility Fracture and BMD<=YAM*70%
|
113 participants
n=99 Participants
|
29 participants
n=107 Participants
|
115 participants
n=206 Participants
|
35 participants
n=7 Participants
|
34 participants
n=31 Participants
|
97 participants
n=30 Participants
|
30 participants
n=3 Participants
|
453 participants
n=6 Participants
|
|
Serum 25-hydroxy Vitamin D (25-OH-D), Categorical
Min - ≤14.9 ng/mL
|
18 participants
n=99 Participants
|
8 participants
n=107 Participants
|
21 participants
n=206 Participants
|
5 participants
n=7 Participants
|
8 participants
n=31 Participants
|
21 participants
n=30 Participants
|
8 participants
n=3 Participants
|
89 participants
n=6 Participants
|
|
Serum 25-hydroxy Vitamin D (25-OH-D), Categorical
15.0 - ≤27.9 ng/mL
|
161 participants
n=99 Participants
|
51 participants
n=107 Participants
|
157 participants
n=206 Participants
|
53 participants
n=7 Participants
|
50 participants
n=31 Participants
|
160 participants
n=30 Participants
|
53 participants
n=3 Participants
|
685 participants
n=6 Participants
|
|
Serum 25-hydroxy Vitamin D (25-OH-D), Categorical
28.0 ng/mL - ≤Max
|
20 participants
n=99 Participants
|
7 participants
n=107 Participants
|
28 participants
n=206 Participants
|
10 participants
n=7 Participants
|
7 participants
n=31 Participants
|
19 participants
n=30 Participants
|
5 participants
n=3 Participants
|
96 participants
n=6 Participants
|
|
Serum 25-OH-D
|
21.55 ng/mL
STANDARD_DEVIATION 5.266 • n=99 Participants
|
21.44 ng/mL
STANDARD_DEVIATION 5.423 • n=107 Participants
|
21.46 ng/mL
STANDARD_DEVIATION 5.592 • n=206 Participants
|
21.64 ng/mL
STANDARD_DEVIATION 5.427 • n=7 Participants
|
21.17 ng/mL
STANDARD_DEVIATION 5.248 • n=31 Participants
|
21.52 ng/mL
STANDARD_DEVIATION 5.121 • n=30 Participants
|
20.58 ng/mL
STANDARD_DEVIATION 4.761 • n=3 Participants
|
21.42 ng/mL
STANDARD_DEVIATION 5.288 • n=6 Participants
|
|
Serum C-telopeptide of Type 1 Collagen (CTX)
|
0.444 ng/mL
STANDARD_DEVIATION 0.1660 • n=99 Participants
|
0.460 ng/mL
STANDARD_DEVIATION 0.1855 • n=107 Participants
|
0.426 ng/mL
STANDARD_DEVIATION 0.1776 • n=206 Participants
|
0.421 ng/mL
STANDARD_DEVIATION 0.1437 • n=7 Participants
|
0.497 ng/mL
STANDARD_DEVIATION 0.1867 • n=31 Participants
|
0.417 ng/mL
STANDARD_DEVIATION 0.1592 • n=30 Participants
|
0.399 ng/mL
STANDARD_DEVIATION 0.1613 • n=3 Participants
|
0.434 ng/mL
STANDARD_DEVIATION 0.1696 • n=6 Participants
|
|
Serum Bone-type Alkaline Phosphatase (BAP)
|
15.91 μg/L
STANDARD_DEVIATION 5.809 • n=99 Participants
|
16.88 μg/L
STANDARD_DEVIATION 8.617 • n=107 Participants
|
15.83 μg/L
STANDARD_DEVIATION 6.035 • n=206 Participants
|
15.45 μg/L
STANDARD_DEVIATION 5.024 • n=7 Participants
|
17.17 μg/L
STANDARD_DEVIATION 7.354 • n=31 Participants
|
15.13 μg/L
STANDARD_DEVIATION 5.164 • n=30 Participants
|
15.13 μg/L
STANDARD_DEVIATION 6.815 • n=3 Participants
|
15.79 μg/L
STANDARD_DEVIATION 6.142 • n=6 Participants
|
|
Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
|
427.1 mU/dL
STANDARD_DEVIATION 154.67 • n=99 Participants
|
424.1 mU/dL
STANDARD_DEVIATION 144.89 • n=107 Participants
|
422.1 mU/dL
STANDARD_DEVIATION 162.07 • n=206 Participants
|
398.4 mU/dL
STANDARD_DEVIATION 127.54 • n=7 Participants
|
444.7 mU/dL
STANDARD_DEVIATION 142.90 • n=31 Participants
|
410.5 mU/dL
STANDARD_DEVIATION 142.09 • n=30 Participants
|
395.0 mU/dL
STANDARD_DEVIATION 128.38 • n=3 Participants
|
418.5 mU/dL
STANDARD_DEVIATION 148.29 • n=6 Participants
|
|
Serum Procollagen 1 N-terminal Peptide (P1NP)
|
51.79 μg/L
STANDARD_DEVIATION 20.357 • n=99 Participants
|
54.91 μg/L
STANDARD_DEVIATION 27.552 • n=107 Participants
|
50.89 μg/L
STANDARD_DEVIATION 22.635 • n=206 Participants
|
47.83 μg/L
STANDARD_DEVIATION 17.120 • n=7 Participants
|
53.43 μg/L
STANDARD_DEVIATION 22.783 • n=31 Participants
|
48.53 μg/L
STANDARD_DEVIATION 20.366 • n=30 Participants
|
46.04 μg/L
STANDARD_DEVIATION 21.714 • n=3 Participants
|
50.44 μg/L
STANDARD_DEVIATION 21.648 • n=6 Participants
|
|
Urine Type 1 Collagen Cross-linked N-telopeptide (NTX)
|
56.76 nmol BCE/mmol-CRE
STANDARD_DEVIATION 26.169 • n=99 Participants
|
61.04 nmol BCE/mmol-CRE
STANDARD_DEVIATION 34.808 • n=107 Participants
|
54.98 nmol BCE/mmol-CRE
STANDARD_DEVIATION 23.928 • n=206 Participants
|
53.77 nmol BCE/mmol-CRE
STANDARD_DEVIATION 22.739 • n=7 Participants
|
64.44 nmol BCE/mmol-CRE
STANDARD_DEVIATION 29.535 • n=31 Participants
|
54.48 nmol BCE/mmol-CRE
STANDARD_DEVIATION 23.988 • n=30 Participants
|
53.66 nmol BCE/mmol-CRE
STANDARD_DEVIATION 23.911 • n=3 Participants
|
56.24 nmol BCE/mmol-CRE
STANDARD_DEVIATION 25.871 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Study (up to Month 12)Population: Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=190 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=194 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=181 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
|
5.07 percent change
Standard Deviation 4.749
|
3.36 percent change
Standard Deviation 4.332
|
4.11 percent change
Standard Deviation 4.654
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
Month 6 (n=190, 62, 194, 61, 59, 181, 63)
|
3.18 percent change
Standard Deviation 4.211
|
1.73 percent change
Standard Deviation 3.635
|
1.92 percent change
Standard Deviation 4.124
|
2.40 percent change
Standard Deviation 3.408
|
3.67 percent change
Standard Deviation 4.841
|
2.70 percent change
Standard Deviation 4.117
|
2.64 percent change
Standard Deviation 4.907
|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
Month 12 (n=178, 58, 180, 58, 55, 171, 60)
|
5.00 percent change
Standard Deviation 4.783
|
3.83 percent change
Standard Deviation 4.227
|
3.53 percent change
Standard Deviation 4.423
|
3.98 percent change
Standard Deviation 3.784
|
5.04 percent change
Standard Deviation 4.387
|
4.05 percent change
Standard Deviation 4.518
|
4.38 percent change
Standard Deviation 5.277
|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
End of Study (n=190, 62, 194, 61, 59, 181, 63)
|
5.07 percent change
Standard Deviation 4.749
|
3.82 percent change
Standard Deviation 4.158
|
3.36 percent change
Standard Deviation 4.332
|
3.93 percent change
Standard Deviation 3.714
|
4.81 percent change
Standard Deviation 4.383
|
4.11 percent change
Standard Deviation 4.654
|
4.36 percent change
Standard Deviation 5.150
|
SECONDARY outcome
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
|
1.10 percent change
Standard Deviation 2.782
|
0.91 percent change
Standard Deviation 2.665
|
0.43 percent change
Standard Deviation 2.666
|
0.54 percent change
Standard Deviation 2.404
|
0.77 percent change
Standard Deviation 2.401
|
0.78 percent change
Standard Deviation 2.420
|
0.55 percent change
Standard Deviation 2.390
|
|
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
|
2.01 percent change
Standard Deviation 3.316
|
1.32 percent change
Standard Deviation 3.399
|
0.95 percent change
Standard Deviation 3.233
|
1.15 percent change
Standard Deviation 3.182
|
1.38 percent change
Standard Deviation 3.013
|
1.45 percent change
Standard Deviation 2.580
|
1.48 percent change
Standard Deviation 2.880
|
|
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
End of Study (n=189, 62, 194, 61, 59, 180, 63)
|
1.96 percent change
Standard Deviation 3.288
|
1.30 percent change
Standard Deviation 3.309
|
0.89 percent change
Standard Deviation 3.172
|
1.15 percent change
Standard Deviation 3.131
|
1.33 percent change
Standard Deviation 2.948
|
1.45 percent change
Standard Deviation 2.565
|
1.39 percent change
Standard Deviation 2.873
|
SECONDARY outcome
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
|
1.34 percent change
Standard Deviation 4.854
|
1.57 percent change
Standard Deviation 3.832
|
0.70 percent change
Standard Deviation 4.324
|
0.80 percent change
Standard Deviation 3.500
|
1.46 percent change
Standard Deviation 3.495
|
1.09 percent change
Standard Deviation 3.141
|
0.53 percent change
Standard Deviation 4.432
|
|
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
|
2.59 percent change
Standard Deviation 6.007
|
1.80 percent change
Standard Deviation 4.030
|
1.36 percent change
Standard Deviation 4.632
|
1.66 percent change
Standard Deviation 4.095
|
2.47 percent change
Standard Deviation 4.129
|
1.94 percent change
Standard Deviation 3.722
|
1.90 percent change
Standard Deviation 4.259
|
|
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
End of Study (n=189, 62, 194, 61, 59, 180, 63)
|
2.52 percent change
Standard Deviation 5.938
|
1.67 percent change
Standard Deviation 3.951
|
1.35 percent change
Standard Deviation 4.551
|
1.64 percent change
Standard Deviation 4.038
|
2.42 percent change
Standard Deviation 4.005
|
1.94 percent change
Standard Deviation 3.661
|
1.85 percent change
Standard Deviation 4.203
|
SECONDARY outcome
Timeframe: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
|
1.07 percent change
Standard Deviation 3.406
|
0.90 percent change
Standard Deviation 3.903
|
0.71 percent change
Standard Deviation 4.205
|
0.49 percent change
Standard Deviation 3.804
|
1.01 percent change
Standard Deviation 3.732
|
0.57 percent change
Standard Deviation 3.572
|
0.67 percent change
Standard Deviation 2.770
|
|
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
|
2.00 percent change
Standard Deviation 4.010
|
0.78 percent change
Standard Deviation 4.302
|
1.34 percent change
Standard Deviation 4.687
|
1.47 percent change
Standard Deviation 4.055
|
1.00 percent change
Standard Deviation 3.799
|
1.24 percent change
Standard Deviation 3.492
|
0.56 percent change
Standard Deviation 4.020
|
|
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
End of Study (n=189, 62, 194, 61, 59, 180, 63)
|
1.96 percent change
Standard Deviation 4.017
|
0.99 percent change
Standard Deviation 4.451
|
1.30 percent change
Standard Deviation 4.638
|
1.55 percent change
Standard Deviation 4.009
|
0.96 percent change
Standard Deviation 3.754
|
1.29 percent change
Standard Deviation 3.578
|
0.52 percent change
Standard Deviation 3.962
|
SECONDARY outcome
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Month 9 (n=185, 60, 185, 59, 55, 175, 61)
|
-52.44 percent change
Standard Deviation 26.256
|
-33.61 percent change
Standard Deviation 27.438
|
-16.75 percent change
Standard Deviation 83.047
|
-27.99 percent change
Standard Deviation 32.106
|
-42.94 percent change
Standard Deviation 24.912
|
-34.50 percent change
Standard Deviation 33.805
|
-30.97 percent change
Standard Deviation 32.819
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
|
-48.98 percent change
Standard Deviation 28.051
|
-32.11 percent change
Standard Deviation 32.662
|
-16.42 percent change
Standard Deviation 64.139
|
-23.68 percent change
Standard Deviation 44.492
|
-40.00 percent change
Standard Deviation 26.613
|
-31.56 percent change
Standard Deviation 36.239
|
-24.62 percent change
Standard Deviation 37.156
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
End of Study (n=199, 66, 204, 68, 65, 200, 66)
|
-47.61 percent change
Standard Deviation 28.275
|
-29.94 percent change
Standard Deviation 36.896
|
-16.27 percent change
Standard Deviation 60.895
|
-24.33 percent change
Standard Deviation 43.256
|
-39.58 percent change
Standard Deviation 26.203
|
-32.33 percent change
Standard Deviation 35.959
|
-26.28 percent change
Standard Deviation 36.284
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Month 1 (n=199, 66, 204, 68, 65, 200, 66)
|
-41.02 percent change
Standard Deviation 27.396
|
-17.42 percent change
Standard Deviation 27.978
|
-15.53 percent change
Standard Deviation 26.107
|
-18.80 percent change
Standard Deviation 25.956
|
-33.52 percent change
Standard Deviation 24.667
|
-24.74 percent change
Standard Deviation 28.675
|
-19.34 percent change
Standard Deviation 28.442
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
|
-47.79 percent change
Standard Deviation 25.044
|
-29.29 percent change
Standard Deviation 22.794
|
-24.80 percent change
Standard Deviation 31.118
|
-28.76 percent change
Standard Deviation 28.409
|
-36.36 percent change
Standard Deviation 23.925
|
-31.30 percent change
Standard Deviation 28.196
|
-29.94 percent change
Standard Deviation 26.889
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
|
-52.42 percent change
Standard Deviation 22.926
|
-36.97 percent change
Standard Deviation 29.126
|
-24.39 percent change
Standard Deviation 38.994
|
-35.33 percent change
Standard Deviation 24.539
|
-44.28 percent change
Standard Deviation 24.390
|
-37.65 percent change
Standard Deviation 28.327
|
-35.13 percent change
Standard Deviation 25.910
|
SECONDARY outcome
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Month 1 (n=199, 66, 205, 68, 65, 200, 66)
|
-3.04 percent change
Standard Deviation 11.881
|
-2.93 percent change
Standard Deviation 13.365
|
-2.61 percent change
Standard Deviation 11.351
|
-3.61 percent change
Standard Deviation 12.135
|
-4.16 percent change
Standard Deviation 13.493
|
-3.69 percent change
Standard Deviation 13.142
|
-2.44 percent change
Standard Deviation 10.662
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
|
-21.56 percent change
Standard Deviation 15.047
|
-13.64 percent change
Standard Deviation 18.499
|
-13.31 percent change
Standard Deviation 17.846
|
-15.99 percent change
Standard Deviation 19.091
|
-24.85 percent change
Standard Deviation 14.835
|
-17.52 percent change
Standard Deviation 18.589
|
-13.83 percent change
Standard Deviation 24.858
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
|
-28.66 percent change
Standard Deviation 19.087
|
-20.92 percent change
Standard Deviation 23.433
|
-17.93 percent change
Standard Deviation 21.202
|
-23.90 percent change
Standard Deviation 18.990
|
-31.06 percent change
Standard Deviation 14.859
|
-24.06 percent change
Standard Deviation 19.744
|
-23.80 percent change
Standard Deviation 18.352
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Month 9 (n=185, 61, 185, 59, 55, 175, 61)
|
-32.84 percent change
Standard Deviation 17.700
|
-25.23 percent change
Standard Deviation 24.949
|
-22.48 percent change
Standard Deviation 22.233
|
-28.00 percent change
Standard Deviation 20.334
|
-33.15 percent change
Standard Deviation 16.226
|
-28.70 percent change
Standard Deviation 19.536
|
-25.84 percent change
Standard Deviation 21.043
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
|
-34.53 percent change
Standard Deviation 20.506
|
-29.23 percent change
Standard Deviation 22.721
|
-24.91 percent change
Standard Deviation 21.537
|
-30.51 percent change
Standard Deviation 17.290
|
-38.06 percent change
Standard Deviation 15.153
|
-29.58 percent change
Standard Deviation 21.560
|
-27.74 percent change
Standard Deviation 21.032
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
End of Study (n=199, 66, 205, 68, 65, 200, 66)
|
-33.34 percent change
Standard Deviation 21.428
|
-26.27 percent change
Standard Deviation 24.287
|
-23.11 percent change
Standard Deviation 21.553
|
-27.21 percent change
Standard Deviation 19.932
|
-33.94 percent change
Standard Deviation 18.140
|
-27.52 percent change
Standard Deviation 21.962
|
-27.08 percent change
Standard Deviation 21.632
|
SECONDARY outcome
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Month 1 (n=199, 66, 205, 68, 65, 200, 66)
|
-32.38 percent change
Standard Deviation 17.664
|
-17.26 percent change
Standard Deviation 20.728
|
-17.49 percent change
Standard Deviation 19.406
|
-21.05 percent change
Standard Deviation 17.749
|
-30.75 percent change
Standard Deviation 19.626
|
-25.20 percent change
Standard Deviation 19.726
|
-22.06 percent change
Standard Deviation 20.097
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
|
-37.27 percent change
Standard Deviation 17.105
|
-25.46 percent change
Standard Deviation 18.567
|
-23.85 percent change
Standard Deviation 22.714
|
-27.46 percent change
Standard Deviation 19.454
|
-33.70 percent change
Standard Deviation 20.735
|
-28.36 percent change
Standard Deviation 20.299
|
-27.13 percent change
Standard Deviation 22.146
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
|
-39.48 percent change
Standard Deviation 17.702
|
-29.15 percent change
Standard Deviation 21.223
|
-23.87 percent change
Standard Deviation 27.077
|
-29.38 percent change
Standard Deviation 20.340
|
-37.16 percent change
Standard Deviation 18.794
|
-31.49 percent change
Standard Deviation 21.748
|
-30.67 percent change
Standard Deviation 21.385
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Month 9 (n=185, 61, 185, 59, 55, 175, 61)
|
-37.64 percent change
Standard Deviation 19.734
|
-25.82 percent change
Standard Deviation 24.762
|
-19.44 percent change
Standard Deviation 45.595
|
-24.78 percent change
Standard Deviation 22.657
|
-32.78 percent change
Standard Deviation 21.561
|
-28.83 percent change
Standard Deviation 24.971
|
-29.71 percent change
Standard Deviation 23.200
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
|
-34.91 percent change
Standard Deviation 20.628
|
-23.70 percent change
Standard Deviation 25.425
|
-13.25 percent change
Standard Deviation 63.783
|
-20.54 percent change
Standard Deviation 26.613
|
-31.03 percent change
Standard Deviation 22.287
|
-24.31 percent change
Standard Deviation 26.832
|
-23.21 percent change
Standard Deviation 25.372
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
End of Study (n=199, 66, 205, 68, 65, 200, 66)
|
-34.76 percent change
Standard Deviation 20.602
|
-22.93 percent change
Standard Deviation 26.532
|
-13.86 percent change
Standard Deviation 60.015
|
-21.29 percent change
Standard Deviation 26.141
|
-31.97 percent change
Standard Deviation 21.945
|
-25.93 percent change
Standard Deviation 26.283
|
-24.46 percent change
Standard Deviation 25.027
|
SECONDARY outcome
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Month 3 (n=192, 63, 194, 64, 59, 184, 63)
|
-45.59 percent change
Standard Deviation 19.379
|
-32.19 percent change
Standard Deviation 27.464
|
-29.09 percent change
Standard Deviation 26.955
|
-34.30 percent change
Standard Deviation 20.730
|
-45.91 percent change
Standard Deviation 22.176
|
-36.80 percent change
Standard Deviation 29.014
|
-34.14 percent change
Standard Deviation 24.153
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Month 6 (n=187, 61, 191, 60, 57, 178, 63)
|
-50.83 percent change
Standard Deviation 22.450
|
-39.51 percent change
Standard Deviation 27.766
|
-33.02 percent change
Standard Deviation 35.354
|
-39.21 percent change
Standard Deviation 23.522
|
-51.40 percent change
Standard Deviation 18.641
|
-42.21 percent change
Standard Deviation 26.918
|
-40.90 percent change
Standard Deviation 26.225
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Month 9 (n=184, 61, 186, 59, 54, 175, 61)
|
-46.82 percent change
Standard Deviation 29.820
|
-34.80 percent change
Standard Deviation 29.523
|
-27.74 percent change
Standard Deviation 38.273
|
-36.41 percent change
Standard Deviation 24.862
|
-46.14 percent change
Standard Deviation 21.531
|
-38.32 percent change
Standard Deviation 30.139
|
-32.09 percent change
Standard Deviation 36.574
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Month 12 (n=180, 55, 179, 59, 53, 170, 60)
|
-42.90 percent change
Standard Deviation 31.614
|
-35.65 percent change
Standard Deviation 27.158
|
-25.32 percent change
Standard Deviation 36.833
|
-31.80 percent change
Standard Deviation 28.472
|
-42.75 percent change
Standard Deviation 24.603
|
-31.33 percent change
Standard Deviation 33.403
|
-29.11 percent change
Standard Deviation 35.904
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
End of Study (n=198, 66, 206, 68, 64, 200, 66)
|
-41.93 percent change
Standard Deviation 31.952
|
-32.03 percent change
Standard Deviation 31.584
|
-25.51 percent change
Standard Deviation 35.324
|
-30.67 percent change
Standard Deviation 27.441
|
-40.82 percent change
Standard Deviation 24.646
|
-31.74 percent change
Standard Deviation 31.892
|
-29.13 percent change
Standard Deviation 34.616
|
|
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Month 1 (n=196, 66, 206, 68, 64, 200, 66)
|
-6.55 percent change
Standard Deviation 17.134
|
-9.08 percent change
Standard Deviation 16.765
|
-7.70 percent change
Standard Deviation 15.206
|
-9.73 percent change
Standard Deviation 16.472
|
-13.68 percent change
Standard Deviation 16.892
|
-9.86 percent change
Standard Deviation 14.908
|
-10.07 percent change
Standard Deviation 15.969
|
SECONDARY outcome
Timeframe: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=66 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=206 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Month 1 (n=199, 66, 206, 68, 65, 200, 66)
|
-32.73 percent change
Standard Deviation 29.296
|
-11.79 percent change
Standard Deviation 38.228
|
-12.42 percent change
Standard Deviation 35.178
|
-17.15 percent change
Standard Deviation 40.458
|
-29.81 percent change
Standard Deviation 29.087
|
-16.42 percent change
Standard Deviation 39.131
|
-12.64 percent change
Standard Deviation 42.198
|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Month 3 (n=193, 63, 194, 65, 60, 184, 63)
|
-37.94 percent change
Standard Deviation 30.360
|
-22.32 percent change
Standard Deviation 35.861
|
-15.64 percent change
Standard Deviation 39.676
|
-20.24 percent change
Standard Deviation 37.412
|
-31.27 percent change
Standard Deviation 28.984
|
-22.60 percent change
Standard Deviation 35.284
|
-20.70 percent change
Standard Deviation 37.137
|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Month 6 (n=188, 61, 191, 60, 58, 178, 63)
|
-35.00 percent change
Standard Deviation 35.405
|
-29.69 percent change
Standard Deviation 37.178
|
-7.96 percent change
Standard Deviation 52.202
|
-19.51 percent change
Standard Deviation 41.804
|
-36.99 percent change
Standard Deviation 28.317
|
-20.79 percent change
Standard Deviation 40.913
|
-20.92 percent change
Standard Deviation 38.419
|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Month 9 (n=185, 61, 186, 59, 55, 175, 61)
|
-30.97 percent change
Standard Deviation 38.541
|
-17.23 percent change
Standard Deviation 38.383
|
-7.71 percent change
Standard Deviation 50.697
|
-19.48 percent change
Standard Deviation 36.149
|
-31.25 percent change
Standard Deviation 26.172
|
-15.90 percent change
Standard Deviation 47.103
|
-14.07 percent change
Standard Deviation 46.266
|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Month 12 (n=181, 55, 179, 59, 54, 170, 60)
|
-35.64 percent change
Standard Deviation 37.715
|
-27.45 percent change
Standard Deviation 33.172
|
-4.66 percent change
Standard Deviation 61.863
|
-24.87 percent change
Standard Deviation 34.422
|
-31.74 percent change
Standard Deviation 34.664
|
-17.68 percent change
Standard Deviation 55.937
|
-21.94 percent change
Standard Deviation 42.649
|
|
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
End of Study (n=199, 66, 206, 68, 65, 200, 66)
|
-35.30 percent change
Standard Deviation 37.274
|
-25.83 percent change
Standard Deviation 32.786
|
-4.72 percent change
Standard Deviation 59.237
|
-23.18 percent change
Standard Deviation 35.863
|
-31.55 percent change
Standard Deviation 35.083
|
-21.06 percent change
Standard Deviation 53.671
|
-24.14 percent change
Standard Deviation 42.102
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.
Outcome measures
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=190 Participants
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=61 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=193 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=62 Participants
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=59 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=178 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=63 Participants
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
Yes
|
2.1 percentage of participants
|
3.3 percentage of participants
|
2.1 percentage of participants
|
3.2 percentage of participants
|
3.4 percentage of participants
|
1.1 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
No
|
97.9 percentage of participants
|
96.7 percentage of participants
|
97.9 percentage of participants
|
96.8 percentage of participants
|
96.6 percentage of participants
|
98.9 percentage of participants
|
98.4 percentage of participants
|
Adverse Events
NE-58095 IR 2.5 mg Once Daily on Awakening
Serious events: 12 serious events
Other events: 128 other events
Deaths: 0 deaths
NE-58095 DR 25 mg Once Monthly on Awakening
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
NE-58095 DR 25 mg Once Monthly Following Breakfast
Serious events: 11 serious events
Other events: 132 other events
Deaths: 0 deaths
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
NE-58095 DR 37.5 mg Once Monthly on Awakening
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
Serious events: 8 serious events
Other events: 138 other events
Deaths: 0 deaths
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 participants at risk
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly on Awakening
n=66 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=206 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Endocrine disorders
Goitre
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Eye disorders
Cataract
|
1.0%
2/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
General disorders
Drowning
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Immune system disorders
Sarcoidosis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Appendicitis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
3/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.0%
2/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Nervous system disorders
Brain stem infarction
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
Other adverse events
| Measure |
NE-58095 IR 2.5 mg Once Daily on Awakening
n=199 participants at risk
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly on Awakening
n=66 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly Following Breakfast
n=206 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
n=68 participants at risk
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly on Awakening
n=65 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
n=200 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
n=66 participants at risk
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
1.0%
2/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
3/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.50%
1/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.5%
9/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.3%
15/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
11.8%
8/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
15.4%
10/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
11.0%
22/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
10/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.1%
4/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.8%
12/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.9%
2/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
10.0%
20/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
3/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.8%
14/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.4%
5/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.5%
15/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
9.1%
6/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.97%
2/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.0%
2/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.1%
4/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
General disorders
Pyrexia
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.4%
9/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.9%
2/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.5%
13/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Immune system disorders
Seasonal allergy
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.97%
2/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.9%
4/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
3/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Nasopharyngitis
|
32.2%
64/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
28.8%
19/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
24.8%
51/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
36.8%
25/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
23.1%
15/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
21.0%
42/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
33.3%
22/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Cystitis
|
1.0%
2/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.9%
8/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.0%
10/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.4%
5/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.4%
3/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.0%
10/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Fall
|
10.6%
21/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
10.6%
7/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.3%
13/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.4%
3/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.5%
15/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.6%
5/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.0%
16/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.6%
5/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.9%
10/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.5%
13/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
10.6%
7/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
8/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.9%
8/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.0%
8/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.5%
5/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.4%
5/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.0%
10/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.0%
14/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.8%
16/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.4%
5/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.5%
11/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
4/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.3%
13/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.9%
2/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.5%
13/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
5/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.1%
4/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.9%
8/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
8.0%
16/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
4.0%
8/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.4%
5/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.9%
2/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
9/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.0%
2/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.49%
1/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.9%
4/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
0.00%
0/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
3/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Nervous system disorders
Headache
|
1.5%
3/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.9%
10/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.9%
4/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.5%
5/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.6%
5/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.5%
9/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.9%
10/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.4%
5/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.2%
4/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.0%
12/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.0%
2/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
10/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.5%
3/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
5.3%
11/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
2.9%
2/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
4.6%
3/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.0%
12/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.1%
4/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
|
Vascular disorders
Hypertension
|
1.0%
2/199 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.5%
1/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.4%
7/206 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
7.4%
5/68 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
3.1%
2/65 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
1.0%
2/200 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
6.1%
4/66 • First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER