Trial Outcomes & Findings for A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70) (NCT NCT04516291)
NCT ID: NCT04516291
Last Updated: 2022-10-04
Results Overview
Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
286 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2022-10-04
Participant Flow
Adult participants aged greater than equal to (\>=) 40 years with dyslipidemia on a stable dose of statin (with or without ezetimibe) were included in the study. The study was conducted across 3 countries.
727 participants signed the inform consent form (ICF). 391 participants were screen failures who did not meet criteria and were not enrolled. 336 participants were enrolled into the study of which 50 participants were not randomized and 286 participants were assigned to a study treatment.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo subcutaneous (SC) injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period (24 Weeks)
STARTED
|
44
|
23
|
24
|
23
|
45
|
45
|
46
|
36
|
|
Treatment Period (24 Weeks)
COMPLETED
|
42
|
18
|
20
|
17
|
33
|
37
|
37
|
22
|
|
Treatment Period (24 Weeks)
NOT COMPLETED
|
2
|
5
|
4
|
6
|
12
|
8
|
9
|
14
|
|
Follow-up Period (12 Weeks)
STARTED
|
44
|
23
|
24
|
23
|
45
|
45
|
46
|
36
|
|
Follow-up Period (12 Weeks)
COMPLETED
|
44
|
22
|
23
|
21
|
43
|
45
|
46
|
36
|
|
Follow-up Period (12 Weeks)
NOT COMPLETED
|
0
|
1
|
1
|
2
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo subcutaneous (SC) injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period (24 Weeks)
Other
|
1
|
0
|
0
|
2
|
2
|
4
|
2
|
0
|
|
Treatment Period (24 Weeks)
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period (24 Weeks)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period (24 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period (24 Weeks)
Adverse Event
|
1
|
2
|
3
|
3
|
9
|
4
|
7
|
14
|
|
Follow-up Period (12 Weeks)
Other
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Follow-up Period (12 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow-up Period (12 Weeks)
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=24 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=36 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.23 Years
STANDARD_DEVIATION 8.09 • n=39 Participants
|
65.78 Years
STANDARD_DEVIATION 7.27 • n=41 Participants
|
64.21 Years
STANDARD_DEVIATION 9.92 • n=35 Participants
|
61.04 Years
STANDARD_DEVIATION 9.31 • n=31 Participants
|
63.38 Years
STANDARD_DEVIATION 8.41 • n=146 Participants
|
63.09 Years
STANDARD_DEVIATION 8.80 • n=19 Participants
|
62.74 Years
STANDARD_DEVIATION 8.64 • n=147 Participants
|
64.47 Years
STANDARD_DEVIATION 7.74 • n=193 Participants
|
63.57 Years
STANDARD_DEVIATION 8.48
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
17 Participants
n=19 Participants
|
20 Participants
n=147 Participants
|
19 Participants
n=193 Participants
|
126 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
28 Participants
n=19 Participants
|
26 Participants
n=147 Participants
|
17 Participants
n=193 Participants
|
160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
41 Participants
n=146 Participants
|
39 Participants
n=19 Participants
|
44 Participants
n=147 Participants
|
35 Participants
n=193 Participants
|
259 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
12 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
44 Participants
n=19 Participants
|
37 Participants
n=147 Participants
|
31 Participants
n=193 Participants
|
250 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set primary (FAS\_primary) included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded.
Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=42 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=35 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
|
-1.1 Percent change
Standard Error 2.76
|
-23.5 Percent change
Standard Error 4.08
|
-23.2 Percent change
Standard Error 4.02
|
-25.3 Percent change
Standard Error 4.23
|
-28.8 Percent change
Standard Error 3.02
|
-27.8 Percent change
Standard Error 2.88
|
-25.8 Percent change
Standard Error 2.84
|
-27.6 Percent change
Standard Error 3.57
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: FAS included all participants randomized to study intervention and who took at least 1 dose of study intervention and had a baseline measurement and at least one post-baseline measurement. Here, "Number Analyzed" signifies participants evaluable for specific rows.
Blood samples were collected from participants in a fasted state for the measurement of TG, ApoB, HDL-C and LDL-C. Fasting was required at least 10 hours before blood sample collection. Non-HDL-C was calculated as total cholesterol minus HDL cholesterol. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=24 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=43 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=36 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16
TG
|
-2.53 Percent change
Standard Deviation 31.247
|
-42.17 Percent change
Standard Deviation 28.081
|
-44.71 Percent change
Standard Deviation 22.725
|
-39.57 Percent change
Standard Deviation 32.546
|
-49.21 Percent change
Standard Deviation 21.049
|
-40.33 Percent change
Standard Deviation 21.311
|
-50.55 Percent change
Standard Deviation 20.234
|
-55.76 Percent change
Standard Deviation 14.625
|
|
Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16
ApoB
|
0.66 Percent change
Standard Deviation 20.372
|
-12.12 Percent change
Standard Deviation 15.839
|
-12.30 Percent change
Standard Deviation 12.604
|
-10.41 Percent change
Standard Deviation 17.067
|
-10.40 Percent change
Standard Deviation 14.690
|
-10.42 Percent change
Standard Deviation 19.332
|
-11.74 Percent change
Standard Deviation 15.560
|
-6.76 Percent change
Standard Deviation 18.890
|
|
Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16
LDL-C
|
-1.42 Percent change
Standard Deviation 24.092
|
-10.40 Percent change
Standard Deviation 31.199
|
-12.61 Percent change
Standard Deviation 21.904
|
-2.09 Percent change
Standard Deviation 26.921
|
-11.38 Percent change
Standard Deviation 22.001
|
-10.88 Percent change
Standard Deviation 26.640
|
-13.78 Percent change
Standard Deviation 19.861
|
-6.30 Percent change
Standard Deviation 29.825
|
|
Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16
Non-HDL-C
|
-3.25 Percent change
Standard Deviation 21.631
|
-21.65 Percent change
Standard Deviation 24.347
|
-24.71 Percent change
Standard Deviation 16.678
|
-20.06 Percent change
Standard Deviation 16.698
|
-24.79 Percent change
Standard Deviation 18.266
|
-21.68 Percent change
Standard Deviation 23.898
|
-27.23 Percent change
Standard Deviation 12.799
|
-22.44 Percent change
Standard Deviation 24.145
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS\_primary included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded. Here, "Number Analyzed" signifies participants evaluable for specific rows.
Fasting was required for all lipid measures at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=42 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=35 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24
LDL-C
|
-1.2 Percent change
Standard Error 3.69
|
-11.2 Percent change
Standard Error 5.41
|
-9.1 Percent change
Standard Error 5.52
|
-12.7 Percent change
Standard Error 5.63
|
-17.3 Percent change
Standard Error 4.00
|
-15.7 Percent change
Standard Error 3.92
|
-9.1 Percent change
Standard Error 3.77
|
-10.2 Percent change
Standard Error 4.74
|
|
Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24
TG
|
-1.8 Percent change
Standard Error 3.71
|
-45.8 Percent change
Standard Error 5.53
|
-45.6 Percent change
Standard Error 5.50
|
-43.1 Percent change
Standard Error 5.76
|
-52.3 Percent change
Standard Error 4.10
|
-47.7 Percent change
Standard Error 3.90
|
-52.5 Percent change
Standard Error 3.85
|
-58.6 Percent change
Standard Error 4.90
|
|
Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24
ApoB
|
0.3 Percent change
Standard Error 2.46
|
-14.8 Percent change
Standard Error 3.60
|
-10.3 Percent change
Standard Error 3.57
|
-11.2 Percent change
Standard Error 3.76
|
-12.2 Percent change
Standard Error 2.68
|
-12.2 Percent change
Standard Error 2.55
|
-5.6 Percent change
Standard Error 2.57
|
-8.1 Percent change
Standard Error 3.17
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: FAS included all participants randomized to study intervention and who took at least 1 dose of study intervention and had a baseline measurement and at least one post-baseline measurement. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
ANGPTL3 is a protein primarily synthesized and secreted by the liver and is a member of the angiopoietin-like family of proteins. Blood samples were collected from participants in a fasted state for the measurement of ANGPTL3. Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=21 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=21 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=21 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=39 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=44 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=41 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=32 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 16
|
9.14 Percent change
Standard Deviation 36.729
|
-51.12 Percent change
Standard Deviation 30.444
|
-63.61 Percent change
Standard Deviation 16.934
|
-58.19 Percent change
Standard Deviation 22.175
|
-65.56 Percent change
Standard Deviation 21.908
|
-60.35 Percent change
Standard Deviation 21.040
|
-77.55 Percent change
Standard Deviation 15.469
|
-75.14 Percent change
Standard Deviation 23.549
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS\_primary included all participants randomized to study intervention and who took at least 1 dose of study intervention, had a baseline measurement and at least one post-baseline measurement with all observations that occurred after discontinuation of treatment or after initiation of severe hypertriglyceridemia excluded. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
ANGPTL3 is a protein primarily synthesized and secreted by the liver and is a member of the angiopoietin-like family of proteins. Blood samples were collected from participants in a fasted state for the measurement of ANGPTL3. Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=22 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=21 Participants
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=22 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=40 Participants
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=42 Participants
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=33 Participants
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in ANGPTL3 at Week 24
|
13.3 Percent change
Standard Error 3.36
|
-56.6 Percent change
Standard Error 4.92
|
-66.3 Percent change
Standard Error 5.01
|
-63.8 Percent change
Standard Error 5.22
|
-73.0 Percent change
Standard Error 3.76
|
-67.1 Percent change
Standard Error 3.46
|
-78.9 Percent change
Standard Error 3.58
|
-81.9 Percent change
Standard Error 4.48
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Vupanorsen: 80 mg Q4W
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Vupanorsen: 60 mg Q2W
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Vupanorsen: 120 mg Q4W
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vupanorsen: 80 mg Q2W
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Vupanorsen: 160 mg Q4W
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Vupanorsen: 120 mg Q2W
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Vupanorsen: 160 mg Q2W
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=44 participants at risk
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 participants at risk
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=24 participants at risk
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 participants at risk
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=45 participants at risk
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 participants at risk
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 participants at risk
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=36 participants at risk
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Cholangitis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Participants were randomized to receive vupanorsen (PF-07285557) matched placebo SC injection. Single or double administration was given at every 2 or 4 weeks (Q2W or Q4W) to match active treatment groups. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q4W
n=23 participants at risk
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 60 mg Q2W
n=24 participants at risk
Participants were randomized to receive vupanorsen 60 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q4W
n=23 participants at risk
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 80 mg Q2W
n=45 participants at risk
Participants were randomized to receive vupanorsen 80 mg single SC injection at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q4W
n=45 participants at risk
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg total) in different locations at Q4W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 120 mg Q2W
n=46 participants at risk
Participants were randomized to receive vupanorsen 60 mg double SC injection (120 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
Vupanorsen: 160 mg Q2W
n=36 participants at risk
Participants were randomized to receive vupanorsen 80 mg double SC injection (160 mg in total) in different locations at Q2W. Administration locations were upper arm, thigh, or abdomen quadrant, as preferred by the participant. Treatment duration was up to 24 weeks. Participants were followed up to 12 weeks after last dose of study intervention.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Haematocrit increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Brugada syndrome
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Myocardial injury
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Cataract
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Ulcerative keratitis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dental necrosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
3/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.6%
2/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.6%
2/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest discomfort
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
3/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Hunger
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site bruising
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site dermatitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site erythema
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
2/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
3/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.1%
4/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site rash
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site reaction
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
3/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.4%
4/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.9%
4/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.9%
4/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
13.0%
6/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.2%
8/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site recall reaction
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
5/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
3/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site vesicles
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Therapeutic response unexpected
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Thirst
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
3/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cystitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis externa
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngitis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.7%
3/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
3/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Animal bite
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
4/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
9/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Albumin urine present
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.1%
4/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood calcium increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood glucose increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood potassium abnormal
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood pressure decreased
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood pressure increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Body temperature increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Creatinine renal clearance abnormal
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
3/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Liver function test increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Magnetic resonance imaging spinal abnormal
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Urine albumin/creatinine ratio abnormal
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Transaminases increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
6/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Gout
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.9%
4/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
3/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.6%
2/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
3/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.7%
3/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
3/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.7%
3/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
2/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascial fibromatosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
13.3%
6/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.7%
3/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Migraine
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
2/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
2/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Microalbuminuria
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Genital atrophy
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.5%
2/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
2/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
1/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hot flush
|
2.3%
1/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
1/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
6.8%
3/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
3/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
1/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/44 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/24 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/23 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
1/45 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/46 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/36 • From start of study intervention up to 12 weeks after last dose of study intervention (maximum for 36 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER