Trial Outcomes & Findings for A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults (NCT NCT03100058)
NCT ID: NCT03100058
Last Updated: 2020-02-06
Results Overview
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
460 participants
Primary outcome timeframe
Baseline, Week 24 (Epoch 3)
Results posted on
2020-02-06
Participant Flow
Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Participant milestones
| Measure |
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25 mg qd (Epoch 4)
LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd
|
LIK066 Bid/LIK066 35 mg qd (Epoch 4)
LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd
|
Placebo/LIK066 25 mg qd (Epoch 4)
Matching placebo tablets for 24 weeks
|
Placebo qd (Epoch 4)
Placebo patients who entered Epoch 4 and received matching Placebo tablets qd
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Epoch 3 (24 Weeks of Treatment)
STARTED
|
38
|
38
|
38
|
77
|
38
|
39
|
38
|
76
|
78
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
COMPLETED
|
35
|
31
|
29
|
63
|
36
|
37
|
30
|
60
|
73
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
NOT COMPLETED
|
3
|
7
|
9
|
14
|
2
|
2
|
8
|
16
|
5
|
0
|
0
|
0
|
0
|
|
Epoch 4 (Last 24 Weeks of the Study)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
158
|
163
|
39
|
34
|
|
Epoch 4 (Last 24 Weeks of the Study)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
153
|
148
|
36
|
30
|
|
Epoch 4 (Last 24 Weeks of the Study)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
15
|
3
|
4
|
Reasons for withdrawal
| Measure |
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25 mg qd (Epoch 4)
LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd
|
LIK066 Bid/LIK066 35 mg qd (Epoch 4)
LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd
|
Placebo/LIK066 25 mg qd (Epoch 4)
Matching placebo tablets for 24 weeks
|
Placebo qd (Epoch 4)
Placebo patients who entered Epoch 4 and received matching Placebo tablets qd
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Epoch 3 (24 Weeks of Treatment)
Adverse Event
|
0
|
0
|
4
|
8
|
1
|
0
|
3
|
11
|
2
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Withdrawal by Subject
|
2
|
4
|
3
|
4
|
1
|
1
|
1
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Non-compliance with study treatment
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 3 (24 Weeks of Treatment)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Epoch 4 (Last 24 Weeks of the Study)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
1
|
|
Epoch 4 (Last 24 Weeks of the Study)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
|
Epoch 4 (Last 24 Weeks of the Study)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
7
|
0
|
2
|
|
Epoch 4 (Last 24 Weeks of the Study)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Epoch 4 (Last 24 Weeks of the Study)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Epoch 4 (Last 24 Weeks of the Study)
non-compliance with study treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Baseline characteristics by cohort
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 12.20 • n=99 Participants
|
53.2 Years
STANDARD_DEVIATION 10.08 • n=107 Participants
|
52.9 Years
STANDARD_DEVIATION 13.60 • n=206 Participants
|
51.1 Years
STANDARD_DEVIATION 12.94 • n=7 Participants
|
53.4 Years
STANDARD_DEVIATION 12.28 • n=31 Participants
|
49.8 Years
STANDARD_DEVIATION 11.50 • n=30 Participants
|
49.7 Years
STANDARD_DEVIATION 11.93 • n=3 Participants
|
52.9 Years
STANDARD_DEVIATION 11.87 • n=6 Participants
|
51.1 Years
STANDARD_DEVIATION 13.27 • n=114 Participants
|
51.7 Years
STANDARD_DEVIATION 12.31
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
49 Participants
n=6 Participants
|
45 Participants
n=114 Participants
|
283 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
27 Participants
n=6 Participants
|
33 Participants
n=114 Participants
|
177 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
42 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
32 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
63 Participants
n=6 Participants
|
64 Participants
n=114 Participants
|
392 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24 (Epoch 3)Population: Full Analysis Set
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at 24 Weeks
|
-1.24 Percent change
Interval -2.5 to -0.45
|
-2.04 Percent change
Interval -3.36 to -0.88
|
-3.52 Percent change
Interval -4.62 to -1.87
|
-4.37 Percent change
Interval -5.36 to -3.37
|
-1.67 Percent change
Interval -2.61 to -0.27
|
-2.51 Percent change
Interval -3.94 to -1.32
|
-4.06 Percent change
Interval -5.52 to -2.87
|
-4.47 Percent change
Interval -5.49 to -3.48
|
-0.63 Percent change
Interval -1.56 to 0.37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=75 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
>=5%
|
26.3 Percentage
|
15.8 Percentage
|
34.2 Percentage
|
42.9 Percentage
|
15.8 Percentage
|
20.5 Percentage
|
37.8 Percentage
|
45.3 Percentage
|
12.8 Percentage
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
>=10%
|
5.3 Percentage
|
5.3 Percentage
|
5.3 Percentage
|
6.5 Percentage
|
5.3 Percentage
|
2.6 Percentage
|
10.8 Percentage
|
9.3 Percentage
|
3.8 Percentage
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=75 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Dysglycemic (>=5%)
|
31.3 Percentage
|
25.0 Percentage
|
40.0 Percentage
|
48.4 Percentage
|
6.7 Percentage
|
37.5 Percentage
|
40.0 Percentage
|
41.9 Percentage
|
9.7 Percentage
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Normoglycemic (>=5%)
|
44.4 Percentage
|
11.1 Percentage
|
44.4 Percentage
|
47.4 Percentage
|
11.1 Percentage
|
11.1 Percentage
|
55.6 Percentage
|
52.9 Percentage
|
20.0 Percentage
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Type 2 Diabetes Mellitus (T2DM) (>=5%)
|
7.7 Percentage
|
15.4 Percentage
|
28.6 Percentage
|
37.0 Percentage
|
28.6 Percentage
|
14.3 Percentage
|
30.8 Percentage
|
44.4 Percentage
|
14.8 Percentage
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline on Waist Circumference
|
-2.1 Percentage Change
Interval -3.87 to -0.31
|
-2.7 Percentage Change
Interval -4.55 to -0.92
|
-3.7 Percentage Change
Interval -5.55 to -1.82
|
-5.6 Percentage Change
Interval -6.84 to -4.35
|
-2.7 Percentage Change
Interval -4.47 to -0.91
|
-4.3 Percentage Change
Interval -6.07 to -2.57
|
-4.8 Percentage Change
Interval -6.61 to -2.98
|
-4.6 Percentage Change
Interval -5.89 to -3.31
|
-1.3 Percentage Change
Interval -2.54 to -0.05
|
-0.4 Percentage Change
Interval -1.25 to 0.36
|
-0.7 Percentage Change
Interval -1.53 to 0.1
|
-2.1 Percentage Change
Interval -3.73 to -0.38
|
0.4 Percentage Change
Interval -1.37 to 2.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)
|
1.9 mmol/L
Interval 0.55 to 3.19
|
-0.1 mmol/L
Interval -1.46 to 1.27
|
-1.2 mmol/L
Interval -2.6 to 0.26
|
-0.8 mmol/L
Interval -1.7 to 0.16
|
-0.5 mmol/L
Interval -1.8 to 0.86
|
-1.1 mmol/L
Interval -2.37 to 0.27
|
-0.9 mmol/L
Interval -2.28 to 0.46
|
-1.0 mmol/L
Interval -1.96 to -0.13
|
0.9 mmol/L
Interval -0.06 to 1.81
|
-0.1 mmol/L
Interval -0.64 to 0.35
|
-0.3 mmol/L
Interval -0.79 to 0.22
|
-0.1 mmol/L
Interval -1.14 to 0.84
|
0.6 mmol/L
Interval -0.54 to 1.73
|
SECONDARY outcome
Timeframe: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)Population: Full Analysis Set
HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)
|
0.1 mmol/L
Interval -0.23 to 0.45
|
-0.5 mmol/L
Interval -0.82 to -0.13
|
-0.9 mmol/L
Interval -1.24 to -0.5
|
-0.7 mmol/L
Interval -0.92 to -0.44
|
-0.3 mmol/L
Interval -0.68 to 0.0
|
-0.5 mmol/L
Interval -0.83 to -0.15
|
-0.6 mmol/L
Interval -0.98 to -0.28
|
-0.6 mmol/L
Interval -0.87 to -0.4
|
-0.3 mmol/L
Interval -0.5 to -0.02
|
0.2 mmol/L
Interval 0.03 to 0.38
|
0.0 mmol/L
Interval -0.13 to 0.22
|
-0.1 mmol/L
Interval -0.49 to 0.24
|
0.3 mmol/L
Interval -0.07 to 0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
systolic blood pressure (SBP)
|
-1.2 mmHg
Interval -4.38 to 1.93
|
-1.5 mmHg
Interval -4.38 to 1.93
|
-4.9 mmHg
Interval -8.3 to -1.52
|
-1.2 mmHg
Interval -3.38 to 1.06
|
-0.7 mmHg
Interval -3.86 to 2.43
|
0.8 mmHg
Interval -2.38 to 3.88
|
-2.6 mmHg
Interval -5.82 to 0.69
|
-1.8 mmHg
Interval -4.15 to 0.48
|
1.6 mmHg
Interval -0.67 to 3.8
|
-0.9 mmHg
Interval -2.66 to 0.79
|
-1.6 mmHg
Interval -3.39 to 0.1
|
-5.6 mmHg
Interval -9.22 to -2.06
|
0.8 mmHg
Interval -2.97 to 4.65
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
diastolic blood pressure (DBP)
|
-0.2 mmHg
Interval -2.37 to 2.0
|
0.1 mmHg
Interval -2.21 to 2.4
|
-2.3 mmHg
Interval -4.62 to 0.07
|
-1.3 mmHg
Interval -2.82 to 0.26
|
0.8 mmHg
Interval -1.35 to 3.02
|
-1.4 mmHg
Interval -3.57 to 0.78
|
0.3 mmHg
Interval -1.99 to 2.54
|
-1.7 mmHg
Interval -3.26 to -0.06
|
0.5 mmHg
Interval -1.03 to 2.08
|
-0.6 mmHg
Interval -1.69 to 0.56
|
-1.2 mmHg
Interval -2.3 to -0.04
|
-2.0 mmHg
Interval -4.33 to 0.34
|
0.6 mmHg
Interval -1.89 to 3.06
|
SECONDARY outcome
Timeframe: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Urinary Glucose Excretion
|
208.6 mmol/24hr
Interval 101.85 to 315.4
|
134.6 mmol/24hr
Interval -8.69 to 277.85
|
377.0 mmol/24hr
Interval 206.19 to 547.9
|
306.1 mmol/24hr
Interval 199.59 to 412.62
|
183.0 mmol/24hr
Interval 32.37 to 333.7
|
193.8 mmol/24hr
Interval 82.22 to 305.31
|
241.3 mmol/24hr
Interval 135.13 to 347.3
|
308.9 mmol/24hr
Interval 198.27 to 419.53
|
-17.8 mmol/24hr
Interval -94.2 to 58.61
|
26.8 mmol/24hr
Interval -30.03 to 83.7
|
122.5 mmol/24hr
Interval 69.82 to 175.26
|
248.0 mmol/24hr
Interval 137.72 to 358.33
|
-148.9 mmol/24hr
Interval -269.62 to -28.1
|
SECONDARY outcome
Timeframe: Between Week 24 and Week 48 (Epoch 4)Population: Full Analysis Set
Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=158 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=163 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=39 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=34 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
|
-0.2 Percentage
Interval -0.7 to 0.33
|
-0.2 Percentage
Interval -0.68 to 0.35
|
-2.4 Percentage
Interval -3.47 to -1.33
|
0.4 Percentage
Interval -0.74 to 1.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set
Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Baseline
|
49.6 mmol/24hr
Standard Deviation 25.08
|
33.1 mmol/24hr
Standard Deviation 29.65
|
40.2 mmol/24hr
Standard Deviation 21.55
|
34.6 mmol/24hr
Standard Deviation 17.56
|
44.7 mmol/24hr
Standard Deviation 26.83
|
43.6 mmol/24hr
Standard Deviation 16.91
|
38.0 mmol/24hr
Standard Deviation 22.13
|
47.9 mmol/24hr
Standard Deviation 23.64
|
43.0 mmol/24hr
Standard Deviation 22.63
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Week 24 (Timepoint 1)
|
48.8 mmol/24hr
Standard Deviation 26.59
|
38.1 mmol/24hr
Standard Deviation 32.20
|
39.8 mmol/24hr
Standard Deviation 22.48
|
40.1 mmol/24hr
Standard Deviation 18.20
|
52.4 mmol/24hr
Standard Deviation 32.78
|
45.9 mmol/24hr
Standard Deviation 15.41
|
38.0 mmol/24hr
Standard Deviation 22.13
|
48.1 mmol/24hr
Standard Deviation 21.93
|
44.7 mmol/24hr
Standard Deviation 23.0
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Week 24 (Timepoint 2)
|
54.2 mmol/24hr
Standard Deviation 29.34
|
42.0 mmol/24hr
Standard Deviation 29.99
|
39.2 mmol/24hr
Standard Deviation 20.24
|
62.8 mmol/24hr
Standard Deviation 34.26
|
51.2 mmol/24hr
Standard Deviation 35.32
|
54.6 mmol/24hr
Standard Deviation 23.77
|
37.9 mmol/24hr
Standard Deviation 32.33
|
53.0 mmol/24hr
Standard Deviation 26.95
|
52.2 mmol/24hr
Standard Deviation 30.75
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Week 24 (Timepoint 3)
|
5.4 mmol/24hr
Standard Deviation 22.74
|
3.9 mmol/24hr
Standard Deviation 19.56
|
-0.6 mmol/24hr
Standard Deviation 12.07
|
22.8 mmol/24hr
Standard Deviation 28.42
|
-1.2 mmol/24hr
Standard Deviation 7.77
|
8.7 mmol/24hr
Standard Deviation 18.21
|
-0.1 mmol/24hr
Standard Deviation 14.39
|
4.9 mmol/24hr
Standard Deviation 26.20
|
7.5 mmol/24hr
Standard Deviation 32.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48Population: Full Analysis Set
Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=158 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=163 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=39 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=34 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Week 48(Timepoint 3)
|
-0.5 mmol/24hr
Standard Deviation 3.41
|
0.4 mmol/24hr
Standard Deviation 2.81
|
0.9 mmol/24hr
Standard Deviation 4.10
|
-1.8 mmol/24hr
Standard Deviation 3.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Baseline
|
4.8 mmol/24hr
Standard Deviation 3.02
|
5.0 mmol/24hr
Standard Deviation 2.84
|
4.6 mmol/24hr
Standard Deviation 0.91
|
5.6 mmol/24hr
Standard Deviation 4.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Week 48(Timepoint 1)
|
5.1 mmol/24hr
Standard Deviation 307
|
5.2 mmol/24hr
Standard Deviation 2.95
|
4.5 mmol/24hr
Standard Deviation 0.95
|
6.6 mmol/24hr
Standard Deviation 4.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Week 48(Timepoint 2)
|
4.6 mmol/24hr
Standard Deviation 2.33
|
5.6 mmol/24hr
Standard Deviation 4.55
|
5.4 mmol/24hr
Standard Deviation 3.65
|
4.8 mmol/24hr
Standard Deviation 2.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: Full Analysis Set
Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Baseline
|
282.1 mmol/24hr
Standard Deviation 128.10
|
240.5 mmol/24hr
Standard Deviation 74.64
|
254.5 mmol/24hr
Standard Deviation 105.70
|
291.5 mmol/24hr
Standard Deviation 175.10
|
284.0 mmol/24hr
Standard Deviation 117.60
|
241.8 mmol/24hr
Standard Deviation 82.75
|
277.0 mmol/24hr
Standard Deviation 99.67
|
293.7 mmol/24hr
Standard Deviation 120.70
|
297.0 mmol/24hr
Standard Deviation 145.10
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Week 24 (Timepoint 1)
|
284.0 mmol/24hr
Standard Deviation 140.10
|
239.7 mmol/24hr
Standard Deviation 80.40
|
260.9 mmol/24hr
Standard Deviation 111.10
|
275.0 mmol/24hr
Standard Deviation 101.30
|
319.9 mmol/24hr
Standard Deviation 32.78
|
246.5 mmol/24hr
Standard Deviation 84.19
|
299.3 mmol/24hr
Standard Deviation 79.06
|
302.5 mmol/24hr
Standard Deviation 121.30
|
307.9 mmol/24hr
Standard Deviation 145.90
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Week 24 (Timepoint 2)
|
297.7 mmol/24hr
Standard Deviation 117.40
|
295.3 mmol/24hr
Standard Deviation 95.60
|
299.2 mmol/24hr
Standard Deviation 145.50
|
264.7 mmol/24hr
Standard Deviation 74.84
|
317.8 mmol/24hr
Standard Deviation 205.10
|
341.6 mmol/24hr
Standard Deviation 109.20
|
260.5 mmol/24hr
Standard Deviation 124.80
|
289.3 mmol/24hr
Standard Deviation 83.62
|
352.8 mmol/24hr
Standard Deviation 159.30
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Week 24 (Timepoint 3)
|
13.0 mmol/24hr
Standard Deviation 132.00
|
55.6 mmol/24hr
Standard Deviation 89.81
|
38.3 mmol/24hr
Standard Deviation 70.00
|
-10.2 mmol/24hr
Standard Deviation 103.60
|
-2.1 mmol/24hr
Standard Deviation 159.60
|
95.1 mmol/24hr
Standard Deviation 67.36
|
-38.7 mmol/24hr
Standard Deviation 107.80
|
-13.2 mmol/24hr
Standard Deviation 153.80
|
44.9 mmol/24hr
Standard Deviation 177.60
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: Full Analysis Set
Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=158 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=163 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=39 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=34 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Baseline
|
27.6 mmol/24hr
Standard Deviation 11.46
|
30.5 mmol/24hr
Standard Deviation 11.63
|
28.6 mmol/24hr
Standard Deviation 14.11
|
40.2 mmol/24hr
Standard Deviation 15.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Week 48 (Timepoint 1)
|
27.5 mmol/24hr
Standard Deviation 11.73
|
30.2 mmol/24hr
Standard Deviation 11.85
|
28.6 mmol/24hr
Standard Deviation 14.11
|
44.4 mmol/24hr
Standard Deviation 17.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Week 48 (Timepoint 2)
|
24.7 mmol/24hr
Standard Deviation 12.74
|
31.1 mmol/24hr
Standard Deviation 16.21
|
31.0 mmol/24hr
Standard Deviation 14.67
|
29.0 mmol/24hr
Standard Deviation 15.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Week 48(Timepoint 3)
|
-2.8 mmol/24hr
Standard Deviation 11.44
|
0.9 mmol/24hr
Standard Deviation 14.52
|
2.4 mmol/24hr
Standard Deviation 17.33
|
-15.5 mmol/24hr
Standard Deviation 18.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Apoliprotein A1
|
8.9 g/L
Interval 4.26 to 13.61
|
8.13 g/L
Interval 3.27 to 13.3
|
10.7 g/L
Interval 5.38 to 15.97
|
8.9 g/L
Interval 5.55 to 12.21
|
5.3 g/L
Interval 0.487 to 10.17
|
8.1 g/L
Interval 3.44 to 12.86
|
6.7 g/L
Interval 1.75 to 11.59
|
11.0 g/L
Interval 7.47 to 14.44
|
6.7 g/L
Interval 3.41 to 10.06
|
3.0 g/L
Interval 0.92 to 5.1
|
3.4 g/L
Interval 1.22 to 5.51
|
5.6 g/L
Interval 1.35 to 9.89
|
-0.7 g/L
Interval -5.27 to 3.87
|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Apoliprotein B
|
2.9 g/L
Interval -5.32 to 11.08
|
7.7 g/L
Interval -1.23 to 16.61
|
3.3 g/L
Interval -6.06 to 12.72
|
12.4 g/L
Interval 6.57 to 18.32
|
-0.4 g/L
Interval -8.91 to 8.18
|
4.5 g/L
Interval -3.84 to 12.74
|
2.3 g/L
Interval -6.36 to 10.98
|
3.9 g/L
Interval -2.29 to 10.01
|
5.8 g/L
Interval -0.03 to 11.69
|
-1.7 g/L
Interval -4.39 to 1.08
|
-2.4 g/L
Interval -5.23 to 0.38
|
-2.3 g/L
Interval -7.85 to 3.31
|
-2.0 g/L
Interval -8.0 to 3.96
|
SECONDARY outcome
Timeframe: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
|
0.99 mg/L
Interval 0.78 to 1.25
|
1.06 mg/L
Interval 0.83 to 1.36
|
1.31 mg/L
Interval 1.01 to 1.69
|
0.98 mg/L
Interval 0.83 to 1.16
|
1.02 mg/L
Interval 0.8 to 1.3
|
0.93 mg/L
Interval 0.74 to 118.0
|
1.00 mg/L
Interval 0.78 to 1.27
|
0.98 mg/L
Interval 0.83 to 1.17
|
0.92 mg/L
Interval 0.78 to 1.09
|
0.95 mg/L
Interval 0.85 to 1.06
|
0.93 mg/L
Interval 0.83 to 1.04
|
0.96 mg/L
Interval 0.77 to 1.2
|
1.07 mg/L
Interval 0.84 to 1.36
|
SECONDARY outcome
Timeframe: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)Population: Full Analysis Set
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=38 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
n=78 Participants
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
n=158 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
n=163 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
n=39 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
n=34 Participants
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Triglycerides (TG)
|
-3.8 mmol/L
Interval -14.91 to 7.26
|
1.3 mmol/L
Interval -11.19 to 13.8
|
-11.5 mmol/L
Interval -24.03 to 0.093
|
-3.0 mmol/L
Interval -10.94 to 4.91
|
2.3 mmol/L
Interval -8.94 to 13.57
|
1.7 mmol/L
Interval -9.3 to 12.77
|
5.5 mmol/L
Interval -5.94 to 16.89
|
-7.4 mmol/L
Interval -15.6 to 0.87
|
4.0 mmol/L
Interval -3.82 to 11.87
|
6.7 mmol/L
Interval 0.18 to 13.13
|
12.4 mmol/L
Interval 5.75 to 19.13
|
-0.9 mmol/L
Interval -14.48 to 12.59
|
4.8 mmol/L
Interval -9.57 to 19.16
|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Total Cholesterol (TC)
|
6.0 mmol/L
Interval -0.92 to 12.99
|
7.3 mmol/L
Interval -0.23 to 14.92
|
4.8 mmol/L
Interval -3.15 to 12.78
|
14.6 mmol/L
Interval 9.61 to 19.58
|
1.5 mmol/L
Interval -5.79 to 8.71
|
5.1 mmol/L
Interval -1.89 to 12.19
|
6.4 mmol/L
Interval -0.94 to 13.75
|
8.8 mmol/L
Interval -0.23 to 9.7
|
4.7 mmol/L
Interval -0.23 to 9.7
|
0.8 mmol/L
Interval -1.65 to 3.27
|
0.3 mmol/L
Interval -2.22 to 2.81
|
0.8 mmol/L
Interval -4.22 to 5.81
|
-1.7 mmol/L
Interval -7.04 to 3.68
|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
HDL Cholesterol
|
0.8 mmol/L
Interval -5.25 to 6.76
|
4.9 mmol/L
Interval -1.52 to 11.28
|
5.2 mmol/L
Interval -1.55 to 12.01
|
8.0 mmol/L
Interval 3.71 to 12.25
|
2.9 mmol/L
Interval -3.29 to 9.16
|
2.4 mmol/L
Interval -3.6 to 8.48
|
1.5 mmol/L
Interval -4.86 to 7.81
|
8.0 mmol/L
Interval 3.56 to 12.47
|
0.7 mmol/L
Interval -3.54 to 5.0
|
3.9 mmol/L
Interval 0.84 to 7.03
|
3.7 mmol/L
Interval 0.54 to 6.9
|
9.2 mmol/L
Interval 2.88 to 15.57
|
0.7 mmol/L
Interval -6.11 to 7.48
|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
LDL Cholesterol
|
8.7 mmol/L
Interval -2.14 to 19.61
|
17.5 mmol/L
Interval 5.73 to 29.2
|
8.2 mmol/L
Interval -4.21 to 20.25
|
21.8 mmol/L
Interval 14.08 to 29.55
|
4.1 mmol/L
Interval -7.22 to 15.38
|
8.7 mmol/L
Interval -2.26 to 19.68
|
7.7 mmol/L
Interval -3.77 to 19.13
|
10.9 mmol/L
Interval 2.8 to 19.04
|
12.5 mmol/L
Interval 4.7 to 20.3
|
-0.6 mmol/L
Interval -4.14 to 2.96
|
-1.2 mmol/L
Interval -4.79 to 2.49
|
-1.4 mmol/L
Interval -8.66 to 5.83
|
-3.5 mmol/L
Interval -11.28 to 4.24
|
SECONDARY outcome
Timeframe: Summary at Week 24 from qd or bid regimensPopulation: Full Analysis Set
Observe maximum plasma concentration following administration of LIK066 (Cmax)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
|
80.0 ng/mL
Standard Deviation 97.2
|
128 ng/mL
Standard Deviation 00.0
|
798 ng/mL
Standard Deviation 397
|
1810 ng/mL
Standard Deviation 545
|
38.6 ng/mL
Standard Deviation 5.22
|
84.2 ng/mL
Standard Deviation 19.0
|
523 ng/mL
Standard Deviation 118
|
811 ng/mL
Standard Deviation 367
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary at Week 24 for qd or bid regimensPopulation: Full Analysis Set
Time to reach the maximum concentration after administration of LIK066 (Tmax)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
|
1.00 hour
Interval 1.0 to 2.0
|
1.00 hour
Interval 1.0 to 1.0
|
1.01 hour
Interval 1.0 to 2.08
|
1.02 hour
Interval 1.0 to 2.0
|
1.00 hour
Interval 0.983 to 1.0
|
1.00 hour
Interval 0.917 to 2.0
|
0.992 hour
Interval 0.9 to 1.0
|
1.00 hour
Interval 0.983 to 2.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary at Week 24 from qd or bid regimens (0-6h)Population: Full Analysis Population
Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
|
196 hr*ng/mL
Standard Deviation 186
|
275 hr*ng/mL
Standard Deviation 000
|
2280 hr*ng/mL
Standard Deviation 522
|
5700 hr*ng/mL
Standard Deviation 1490
|
105 hr*ng/mL
Standard Deviation 17.1
|
273 hr*ng/mL
Standard Deviation 69.3
|
1520 hr*ng/mL
Standard Deviation 277
|
2190 hr*ng/mL
Standard Deviation 841
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary at Week 24 from qd or bid regimensPopulation: Full Analysis Set
Last non-zero concentration area under the curve (AUClast)
Outcome measures
| Measure |
LIK066 2.5mg qd (Epoch 3)
n=38 Participants
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 10mg qd (Epoch 3)
n=38 Participants
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50mg qd (Epoch 3)
n=38 Participants
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150mg qd (Epoch 3)
n=77 Participants
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5mg Bid (Epoch 3)
n=38 Participants
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5mg Bid (Epoch 3)
n=39 Participants
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25mg Bid (Epoch 3)
n=37 Participants
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50mg Bid (Epoch 3)
n=76 Participants
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
|
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
|
196 hr*ng/mL
Standard Deviation 186
|
275 hr*ng/mL
Standard Deviation 000
|
2290 hr*ng/mL
Standard Deviation 526
|
5690 hr*ng/mL
Standard Deviation 1480
|
105 hr*ng/mL
Standard Deviation 17.2
|
273 hr*ng/mL
Standard Deviation 70.2
|
1520 hr*ng/mL
Standard Deviation 271
|
2190 hr*ng/mL
Standard Deviation 843
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
LIK066 10 mg qd/25 mg qd
Serious events: 3 serious events
Other events: 24 other events
Deaths: 1 deaths
LIK066 50 mg qd/25 mg qd
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
LIK066 150 mg qd/25 mg qd
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
LIK066 2.5 mg Bid/35 mg qd
Serious events: 5 serious events
Other events: 31 other events
Deaths: 1 deaths
LIK066 5 mg Bid/35 mg qd
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
LIK066 25 mg Bid/35 mg qd
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
LIK066 50 mg Bid/35 mg qd
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo/LIK066 25 mg qd (Epoch 4)
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo/Placebo
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)
n=38 participants at risk
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4)
|
LIK066 10 mg qd/25 mg qd
n=38 participants at risk
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50 mg qd/25 mg qd
n=38 participants at risk
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150 mg qd/25 mg qd
n=77 participants at risk
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5 mg Bid/35 mg qd
n=38 participants at risk
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5 mg Bid/35 mg qd
n=39 participants at risk
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25 mg Bid/35 mg qd
n=38 participants at risk
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50 mg Bid/35 mg qd
n=76 participants at risk
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo/LIK066 25 mg qd (Epoch 4)
n=40 participants at risk
Matching placebo tablets for 24 weeks
|
Placebo/Placebo
n=38 participants at risk
Matching placebo tablets
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
Other adverse events
| Measure |
LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)
n=38 participants at risk
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4)
|
LIK066 10 mg qd/25 mg qd
n=38 participants at risk
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 50 mg qd/25 mg qd
n=38 participants at risk
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 150 mg qd/25 mg qd
n=77 participants at risk
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
|
LIK066 2.5 mg Bid/35 mg qd
n=38 participants at risk
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 5 mg Bid/35 mg qd
n=39 participants at risk
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 25 mg Bid/35 mg qd
n=38 participants at risk
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
|
LIK066 50 mg Bid/35 mg qd
n=76 participants at risk
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
|
Placebo/LIK066 25 mg qd (Epoch 4)
n=40 participants at risk
Matching placebo tablets for 24 weeks
|
Placebo/Placebo
n=38 participants at risk
Matching placebo tablets
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Congenital, familial and genetic disorders
Type IIa hyperlipidaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Cataract
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Myopic chorioretinal degeneration
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Ulcerative keratitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
7/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.4%
8/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
23.7%
9/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
12.8%
5/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
6/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
7/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
4/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
15.8%
6/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
15.8%
6/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
14.3%
11/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
31.6%
12/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
12.8%
5/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
21.1%
8/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
8/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
17.5%
7/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
23.7%
9/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
7/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.8%
14/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
39.5%
15/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
54.5%
42/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
42.1%
16/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
30.8%
12/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
36.8%
14/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
38.2%
29/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
35.0%
14/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
21.1%
8/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Dyschezia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
26.3%
10/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
12.8%
5/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
6/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
26.3%
10/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Eructation
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.5%
5/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
4/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Faeces hard
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Flatulence
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
23.7%
9/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
23.7%
9/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
27.3%
21/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
31.6%
12/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
15.4%
6/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
28.9%
11/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
27.6%
21/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
21.1%
8/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.5%
5/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
4/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
21.1%
8/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
4/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
12.5%
5/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Asthenia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Chest pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Chills
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Hunger
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
General disorders
Thirst
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Immune system disorders
Seasonal allergy
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Eye infection
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Folliculitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Genital herpes zoster
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Hordeolum
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Influenza
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.4%
8/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
18.4%
7/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.6%
5/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Otitis externa fungal
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Sinusitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tonsillitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tooth abscess
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tooth infection
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
7/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
12.5%
5/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.3%
4/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
4/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.2%
4/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Amylase decreased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Apolipoprotein A-I decreased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood albumin increased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood glucose increased
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood magnesium decreased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Creatinine urine increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Electrocardiogram change
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Glomerular filtration rate increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Haematocrit increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Haemoglobin urine present
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Heart rate decreased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Heart rate irregular
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Lipase abnormal
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Liver scan abnormal
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Protein urine present
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Serum ferritin decreased
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
13.2%
5/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Urine leukocyte esterase
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Investigations
Weight increased
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.8%
6/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.5%
4/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
9.1%
7/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
10.3%
4/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
6.6%
5/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of conjunctiva
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.7%
3/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Nerve compression
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Sciatica
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Product Issues
Device dislocation
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
3.9%
3/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Binge drinking
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Depression
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Grief reaction
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Stress
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Proteinuria
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Breast haematoma
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.2%
4/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.3%
2/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
2/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hot flush
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
1.3%
1/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
7.9%
3/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
5.1%
2/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.6%
1/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/77 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/39 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/76 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
0.00%
0/38 • Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER