Trial Outcomes & Findings for Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes (NCT NCT01923181)
NCT ID: NCT01923181
Last Updated: 2021-01-15
Results Overview
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
632 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2021-01-15
Participant Flow
The trial was conducted at 100 sites in 14 countries as follows: Austria (6), Bulgaria (3), Canada (6), Denmark (6), Germany (6), Israel (6), Italy (4), Malaysia (4), Serbia (1), South Africa (3), Spain (5), Sweden (3), United Kingdom (8) and United States (39).
Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participant milestones
| Measure |
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
69
|
70
|
71
|
70
|
70
|
69
|
71
|
|
Overall Study
Full Analysis Set (FAS)
|
70
|
70
|
69
|
70
|
71
|
70
|
70
|
69
|
71
|
|
Overall Study
Safety Analysis Set (SAS)
|
70
|
70
|
69
|
70
|
71
|
70
|
70
|
69
|
71
|
|
Overall Study
COMPLETED
|
67
|
64
|
67
|
65
|
63
|
66
|
62
|
61
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
2
|
5
|
8
|
4
|
8
|
8
|
3
|
Reasons for withdrawal
| Measure |
Oral Semaglutide 2.5 mg
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Subcutaneous Semaglutide 1 mg
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
0
|
2
|
2
|
1
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
4
|
2
|
4
|
3
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
1
|
2
|
1
|
3
|
3
|
1
|
Baseline Characteristics
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Oral Semaglutide 2.5 mg
n=70 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=69 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=71 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Subcutaneous Semaglutide 1 mg
n=69 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
n=71 Participants
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
Total
n=630 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
55.7 Years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
56.5 Years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
58.3 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
56.5 Years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
57.1 Years
STANDARD_DEVIATION 10.5 • n=30 Participants
|
57.7 Years
STANDARD_DEVIATION 10.8 • n=3 Participants
|
56.8 Years
STANDARD_DEVIATION 11.8 • n=6 Participants
|
58.9 Years
STANDARD_DEVIATION 10.3 • n=114 Participants
|
57.1 Years
STANDARD_DEVIATION 10.6
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
29 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
31 Participants
n=114 Participants
|
235 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
44 Participants
n=3 Participants
|
48 Participants
n=6 Participants
|
40 Participants
n=114 Participants
|
395 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
61 Participants
n=30 Participants
|
58 Participants
n=3 Participants
|
62 Participants
n=6 Participants
|
62 Participants
n=114 Participants
|
559 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
54 Participants
n=30 Participants
|
59 Participants
n=3 Participants
|
54 Participants
n=6 Participants
|
57 Participants
n=114 Participants
|
523 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
47 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
50 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
7 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.99 Percentage of HbA1c
STANDARD_DEVIATION 0.72 • n=99 Participants
|
7.80 Percentage of HbA1c
STANDARD_DEVIATION 0.62 • n=107 Participants
|
7.80 Percentage of HbA1c
STANDARD_DEVIATION 0.70 • n=206 Participants
|
7.86 Percentage of HbA1c
STANDARD_DEVIATION 0.69 • n=7 Participants
|
8.05 Percentage of HbA1c
STANDARD_DEVIATION 0.75 • n=31 Participants
|
7.96 Percentage of HbA1c
STANDARD_DEVIATION 0.73 • n=30 Participants
|
7.77 Percentage of HbA1c
STANDARD_DEVIATION 0.75 • n=3 Participants
|
7.77 Percentage of HbA1c
STANDARD_DEVIATION 0.71 • n=6 Participants
|
8.00 Percentage of HbA1c
STANDARD_DEVIATION 0.80 • n=114 Participants
|
7.89 Percentage of HbA1c
STANDARD_DEVIATION 0.73
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: Overall number of participants analyzed = number of participants with available data.
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=56 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=58 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=48 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=46 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=52 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=44 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=90 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=48 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
n=51 Participants
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin)
|
-0.88 Percentage of HbA1c
Standard Deviation 0.77
|
-1.23 Percentage of HbA1c
Standard Deviation 0.79
|
-1.56 Percentage of HbA1c
Standard Deviation 0.92
|
-1.70 Percentage of HbA1c
Standard Deviation 0.75
|
-2.04 Percentage of HbA1c
Standard Deviation 0.90
|
-1.76 Percentage of HbA1c
Standard Deviation 0.92
|
-1.65 Percentage of HbA1c
Standard Deviation 0.77
|
-1.85 Percentage of HbA1c
Standard Deviation 0.86
|
-1.85 Percentage of HbA1c
Standard Deviation 0.75
|
-0.40 Percentage of HbA1c
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: Overall number of participants analyzed = number of participants with available data.
Participants who achieved HbA1c \<7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=56 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=58 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=48 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=46 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=52 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=44 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=48 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=51 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Yes
|
27 Participants
|
50 Participants
|
49 Participants
|
41 Participants
|
42 Participants
|
47 Participants
|
38 Participants
|
45 Participants
|
18 Participants
|
—
|
|
Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
No
|
29 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: Overall number of participants analyzed = number of participants with available data.
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=56 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=47 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=46 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=51 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=44 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=46 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=51 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Body Weight
|
-2.01 kg
Standard Deviation 3.08
|
-2.89 kg
Standard Deviation 3.32
|
-4.90 kg
Standard Deviation 4.04
|
-5.75 kg
Standard Deviation 5.63
|
-6.91 kg
Standard Deviation 4.57
|
-5.93 kg
Standard Deviation 4.34
|
-8.29 kg
Standard Deviation 5.27
|
-6.71 kg
Standard Deviation 3.18
|
-1.16 kg
Standard Deviation 2.59
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Overall number of participants analyzed = number of participants with available data.
Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=56 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=56 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=47 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=46 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=51 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=44 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=46 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=51 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Waist Circumference
|
-2.00 cm
Standard Deviation 4.31
|
-2.29 cm
Standard Deviation 4.54
|
-5.28 cm
Standard Deviation 5.55
|
-4.08 cm
Standard Deviation 4.01
|
-5.71 cm
Standard Deviation 4.65
|
-4.86 cm
Standard Deviation 5.48
|
-6.24 cm
Standard Deviation 4.71
|
-6.34 cm
Standard Deviation 4.65
|
-2.29 cm
Standard Deviation 3.99
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Overall number of participants analyzed = number of participants with available data.
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=56 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=57 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=47 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=46 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=51 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=44 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=46 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=51 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.67 kg/m^2
Standard Deviation 0.98
|
-0.98 kg/m^2
Standard Deviation 1.14
|
-1.72 kg/m^2
Standard Deviation 1.44
|
-1.93 kg/m^2
Standard Deviation 1.87
|
-2.37 kg/m^2
Standard Deviation 1.58
|
-2.04 kg/m^2
Standard Deviation 1.45
|
-2.92 kg/m^2
Standard Deviation 1.93
|
-2.32 kg/m^2
Standard Deviation 1.04
|
-0.43 kg/m^2
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-31Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=70 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=69 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=71 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=69 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=71 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
|
142 Events
|
169 Events
|
233 Events
|
289 Events
|
230 Events
|
233 Events
|
245 Events
|
218 Events
|
127 Events
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-31Population: Overall number of participants analyzed = SAS which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
Oral Semaglutide 2.5 mg
n=70 Participants
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=69 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=71 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=70 Participants
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Oral Semaglutide 40 mg Pooled
n=69 Participants
The data from participants in oral semaglutide 40 mg arm and oral semaglutide fast dose-escalation arm were pooled in this arm.
|
Subcutaneous Semaglutide 1 mg
n=71 Participants
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Confirmed Hypoglycaemic Episodes Recorded
|
4 Episodes
|
4 Episodes
|
6 Episodes
|
1 Episodes
|
1 Episodes
|
3 Episodes
|
1 Episodes
|
6 Episodes
|
5 Episodes
|
—
|
Adverse Events
Oral Semaglutide 2.5 mg
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Oral Semaglutide 5 mg
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Oral Semaglutide 10 mg
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Oral Semaglutide 20 mg
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Oral Semaglutide 40 mg
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Oral Semaglutide 40 mg Slow Dose-escalation
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Oral Semaglutide 40 mg Fast Dose-escalation
Serious events: 5 serious events
Other events: 55 other events
Deaths: 0 deaths
Subcutaneous Semaglutide 1 mg
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Semaglutide 2.5 mg
n=70 participants at risk
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=69 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=71 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Subcutaneous Semaglutide 1 mg
n=69 participants at risk
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
n=71 participants at risk
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Eye disorders
Pterygium
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
Other adverse events
| Measure |
Oral Semaglutide 2.5 mg
n=70 participants at risk
Participants were to take 2.5 mg oral semaglutide tablets once daily for 26 weeks. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 5 mg
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 2.5 mg from week 1 to 4 and 5 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 10 mg
n=69 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4 and 10 mg from week 5 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 20 mg
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8 and 20 mg from week 9 to 26.
Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg
n=71 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 4, 10 mg from week 5 to 8, 20 mg from week 9 to 12 and 40 mg from week 13 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Slow Dose-escalation
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 8, 10 mg from week 9 to 16, 20 mg from week 17 to 24 and 40 mg from week 25 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets.
|
Oral Semaglutide 40 mg Fast Dose-escalation
n=70 participants at risk
Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 1 to 26: 5 mg from week 1 to 2, 10 mg from week 3 to 4, 20 mg from week 5 to 6 and 40 mg from week 7 to 26. Semaglutide tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than semaglutide tablets could be taken upto 2 hours prior to administration of semaglutide tablets. The semaglutide tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide tablets. Oral medication other than semaglutide tablets could only be taken 2 hours after administration of semaglutide tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide tablets
|
Subcutaneous Semaglutide 1 mg
n=69 participants at risk
Participants were to administer subcutaneous semaglutide injections once weekly in a dose escalation manner from week 1 to 26: 0.25 mg from week 1 to 4, 0.50 mg from week 5 to 8 and 1.0 mg from week 9 to 26. Semaglutide injections were to be administered in the thigh, abdomen or upper arm, at any time of day (same day of the week) irrespective of meals.
|
Placebo
n=71 participants at risk
Participants were to take oral semaglutide placebo tablets once daily from week 1 to 26. Semaglutide placebo tablets were to be taken once daily in the morning in a fasting state (atleast for 6 hours). Water and oral medication other than the semaglutide placebo tablets could be taken upto 2 hours prior to administration of semaglutide placebo tablets. The semaglutide placebo tablets could be taken with up to 120 mL of water. Participants were not allowed to take food and water for at least 30 minutes after administration of semaglutide placebo tablets. Oral medication other than semaglutide placebo tablets could only be taken 2 hours after administration of semaglutide placebo tablets. If taken along with food, oral medication could be administered 30 minutes after administration of semaglutide placebo tablets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
3/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.5%
10/69 • Number of events 10 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
11.4%
8/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.1%
10/71 • Number of events 11 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
15.7%
11/70 • Number of events 11 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
13.0%
9/69 • Number of events 9 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.2%
5/69 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.5%
6/71 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.0%
5/71 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
3/71 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.8%
4/69 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.6%
6/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.7%
6/69 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.7%
9/71 • Number of events 11 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
10.0%
7/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
11.4%
8/70 • Number of events 9 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
10.1%
7/69 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.8%
4/69 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
5/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
10.0%
7/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
23.2%
16/69 • Number of events 20 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
20.0%
14/70 • Number of events 18 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.1%
10/71 • Number of events 15 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
20.0%
14/70 • Number of events 27 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
17.1%
12/70 • Number of events 15 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.5%
10/69 • Number of events 14 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
9.9%
7/71 • Number of events 10 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Nervous system disorders
Dizziness
|
7.1%
5/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
2/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.7%
6/69 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
11.4%
8/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.5%
6/71 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.6%
6/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.5%
10/69 • Number of events 11 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
3/71 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.0%
5/71 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
General disorders
Fatigue
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.8%
4/69 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Nervous system disorders
Headache
|
5.7%
4/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.9%
9/70 • Number of events 9 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
11.6%
8/69 • Number of events 10 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.3%
10/70 • Number of events 18 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
11.4%
8/70 • Number of events 10 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
10.0%
7/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.5%
10/69 • Number of events 21 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Vascular disorders
Hypertension
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.6%
6/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Influenza
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.0%
5/71 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Investigations
Lipase increased
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/70 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
3/71 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.8%
2/71 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
6/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.1%
5/70 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
7.0%
5/71 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/69 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.7%
9/71 • Number of events 9 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Nausea
|
12.9%
9/70 • Number of events 12 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
14.3%
10/70 • Number of events 13 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
33.3%
23/69 • Number of events 27 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
35.7%
25/70 • Number of events 37 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
33.8%
24/71 • Number of events 37 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
32.9%
23/70 • Number of events 29 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
35.7%
25/70 • Number of events 27 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
31.9%
22/69 • Number of events 23 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.6%
6/70 • Number of events 7 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.8%
4/69 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/71 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
4/70 • Number of events 8 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.7%
4/70 • Number of events 5 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
20.3%
14/69 • Number of events 18 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
17.1%
12/70 • Number of events 15 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
19.7%
14/71 • Number of events 25 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
15.7%
11/70 • Number of events 22 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
22.9%
16/70 • Number of events 20 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.7%
6/69 • Number of events 6 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
3/71 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Investigations
Weight decreased
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/69 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.9%
2/70 • Number of events 2 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
5.6%
4/71 • Number of events 4 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/70 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.3%
3/70 • Number of events 3 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
1.4%
1/69 • Number of events 1 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/71 • Week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
- Publication restrictions are in place
Restriction type: OTHER