Trial Outcomes & Findings for The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial (NCT NCT00347360)
NCT ID: NCT00347360
Last Updated: 2016-12-26
Results Overview
Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
654 participants
Primary outcome timeframe
Baseline, Week 6.
Results posted on
2016-12-26
Participant Flow
Participant milestones
| Measure |
Lisinopril 10
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
lisinopril 20 mg once daily
|
Lisinopril 40
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
43
|
43
|
44
|
44
|
44
|
43
|
44
|
44
|
44
|
43
|
44
|
44
|
43
|
|
Overall Study
COMPLETED
|
39
|
35
|
37
|
30
|
39
|
36
|
37
|
40
|
38
|
35
|
39
|
37
|
34
|
36
|
39
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
6
|
13
|
5
|
8
|
7
|
3
|
6
|
9
|
5
|
6
|
10
|
8
|
4
|
Reasons for withdrawal
| Measure |
Lisinopril 10
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
lisinopril 20 mg once daily
|
Lisinopril 40
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
4
|
1
|
2
|
2
|
0
|
2
|
3
|
3
|
1
|
3
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
1
|
1
|
2
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
3
|
1
|
2
|
1
|
2
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
4
|
1
|
2
|
1
|
1
|
1
|
1
|
0
|
3
|
4
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
3
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not listed/blank
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Per sponsors instruction
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
P.I. recommended due to blood pressure
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject did not meet end of study ABPM
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Abnormal lab values
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PI recommended early withdrawal
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not meet criteria before ABPM
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized in error
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Failed inclusion criteria #4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Prolonged duration between visits
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject left town, ran out of study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject refuse to sign updated consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Visits conflicted with new job
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
Baseline characteristics by cohort
| Measure |
Lisinopril 10
n=44 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=43 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=43 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=43 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=44 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=44 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=44 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=43 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=44 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=44 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=44 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=43 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=44 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=44 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=43 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 10.69 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 10.70 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 9.41 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 10.94 • n=21 Participants
|
54.3 years
STANDARD_DEVIATION 8.64 • n=8 Participants
|
53.3 years
STANDARD_DEVIATION 9.60 • n=8 Participants
|
55.5 years
STANDARD_DEVIATION 8.39 • n=24 Participants
|
53.5 years
STANDARD_DEVIATION 10.51 • n=42 Participants
|
51.9 years
STANDARD_DEVIATION 9.08 • n=42 Participants
|
51.5 years
STANDARD_DEVIATION 9.32 • n=42 Participants
|
57.9 years
STANDARD_DEVIATION 9.27 • n=42 Participants
|
52.5 years
STANDARD_DEVIATION 11.11 • n=36 Participants
|
50.9 years
STANDARD_DEVIATION 9.51 • n=36 Participants
|
51.5 years
STANDARD_DEVIATION 8.69 • n=24 Participants
|
53.1 years
STANDARD_DEVIATION 9.86 • n=135 Participants
|
|
Gender
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
232 Participants
n=135 Participants
|
|
Gender
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
29 Participants
n=24 Participants
|
422 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
9 participants
n=5 Participants
|
16 participants
n=4 Participants
|
11 participants
n=21 Participants
|
13 participants
n=8 Participants
|
12 participants
n=8 Participants
|
11 participants
n=24 Participants
|
12 participants
n=42 Participants
|
18 participants
n=42 Participants
|
14 participants
n=42 Participants
|
13 participants
n=42 Participants
|
16 participants
n=36 Participants
|
14 participants
n=36 Participants
|
11 participants
n=24 Participants
|
194 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=36 Participants
|
1 participants
n=36 Participants
|
0 participants
n=24 Participants
|
2 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
2 participants
n=8 Participants
|
1 participants
n=24 Participants
|
2 participants
n=42 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
1 participants
n=42 Participants
|
3 participants
n=36 Participants
|
3 participants
n=36 Participants
|
4 participants
n=24 Participants
|
33 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
26 participants
n=4 Participants
|
30 participants
n=21 Participants
|
29 participants
n=8 Participants
|
30 participants
n=8 Participants
|
30 participants
n=24 Participants
|
29 participants
n=42 Participants
|
23 participants
n=42 Participants
|
27 participants
n=42 Participants
|
27 participants
n=42 Participants
|
25 participants
n=36 Participants
|
26 participants
n=36 Participants
|
27 participants
n=24 Participants
|
417 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race not provided by patient
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
1 participants
n=24 Participants
|
7 participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6.Population: ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.
Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure
|
-5.79 mmHg
Standard Deviation 5.922
|
-8.11 mmHg
Standard Deviation 8.811
|
-7.37 mmHg
Standard Deviation 5.914
|
-4.40 mmHg
Standard Deviation 5.182
|
-7.61 mmHg
Standard Deviation 4.880
|
-6.52 mmHg
Standard Deviation 6.408
|
-9.29 mmHg
Standard Deviation 7.226
|
-8.57 mmHg
Standard Deviation 6.585
|
-10.19 mmHg
Standard Deviation 6.899
|
-9.36 mmHg
Standard Deviation 7.426
|
-10.96 mmHg
Standard Deviation 8.388
|
-10.37 mmHg
Standard Deviation 7.234
|
-10.93 mmHg
Standard Deviation 5.517
|
-11.09 mmHg
Standard Deviation 8.719
|
-11.92 mmHg
Standard Deviation 6.887
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Trough ABPM was the average across 20-24 hr after dosing for each subject.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=29 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=33 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=35 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=29 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=33 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=33 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Trough Diastolic Blood Pressure
|
-6.40 mmHg
Standard Deviation 7.982
|
-6.08 mmHg
Standard Deviation 8.735
|
-8.16 mmHg
Standard Deviation 7.299
|
-2.34 mmHg
Standard Deviation 7.060
|
-7.76 mmHg
Standard Deviation 8.285
|
-5.26 mmHg
Standard Deviation 9.530
|
-5.14 mmHg
Standard Deviation 7.002
|
-6.36 mmHg
Standard Deviation 9.080
|
-7.22 mmHg
Standard Deviation 11.284
|
-6.79 mmHg
Standard Deviation 9.210
|
-7.76 mmHg
Standard Deviation 11.202
|
-4.90 mmHg
Standard Deviation 8.508
|
-6.54 mmHg
Standard Deviation 8.305
|
-7.26 mmHg
Standard Deviation 9.345
|
-8.42 mmHg
Standard Deviation 7.903
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure
|
-9.19 mmHg
Standard Deviation 9.415
|
-13.58 mmHg
Standard Deviation 16.429
|
-10.60 mmHg
Standard Deviation 8.842
|
-6.15 mmHg
Standard Deviation 6.887
|
-9.84 mmHg
Standard Deviation 8.471
|
-10.38 mmHg
Standard Deviation 8.204
|
-12.06 mmHg
Standard Deviation 11.058
|
-11.58 mmHg
Standard Deviation 11.112
|
-14.16 mmHg
Standard Deviation 10.783
|
-11.68 mmHg
Standard Deviation 10.218
|
-14.03 mmHg
Standard Deviation 11.954
|
-13.90 mmHg
Standard Deviation 10.237
|
-15.60 mmHg
Standard Deviation 9.777
|
-15.93 mmHg
Standard Deviation 12.501
|
-15.59 mmHg
Standard Deviation 11.055
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Trough ABPM was the average across 20-24 hr after dosing for each subject.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=29 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=33 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=35 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=29 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=33 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=33 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Trough Systolic Blood Pressure
|
-9.47 mmHg
Standard Deviation 13.301
|
-7.52 mmHg
Standard Deviation 12.221
|
-9.54 mmHg
Standard Deviation 9.968
|
-0.96 mmHg
Standard Deviation 11.447
|
-9.27 mmHg
Standard Deviation 12.362
|
-5.68 mmHg
Standard Deviation 14.539
|
-6.44 mmHg
Standard Deviation 9.739
|
-9.27 mmHg
Standard Deviation 13.582
|
-9.88 mmHg
Standard Deviation 14.356
|
-8.87 mmHg
Standard Deviation 11.954
|
-8.11 mmHg
Standard Deviation 13.732
|
-5.82 mmHg
Standard Deviation 13.878
|
-9.80 mmHg
Standard Deviation 11.196
|
-10.74 mmHg
Standard Deviation 12.813
|
-10.00 mmHg
Standard Deviation 12.091
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)
|
-5.77 mmHg
Standard Error 0.821
|
-7.55 mmHg
Standard Error 0.717
|
-7.49 mmHg
Standard Error 0.877
|
-5.11 mmHg
Standard Error 0.821
|
-6.61 mmHg
Standard Error 0.718
|
-7.13 mmHg
Standard Error 0.925
|
-8.08 mmHg
Standard Error 0.472
|
-9.83 mmHg
Standard Error 0.536
|
-9.71 mmHg
Standard Error 0.657
|
-9.55 mmHg
Standard Error 0.534
|
-11.3 mmHg
Standard Error 0.645
|
-11.1 mmHg
Standard Error 0.702
|
-10.0 mmHg
Standard Error 0.696
|
-11.7 mmHg
Standard Error 0.722
|
-11.4 mmHg
Standard Error 1.042
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak \> 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=29 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=33 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=35 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=29 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=33 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)
|
133.33 trough:peak ratio x 100%
|
61.04 trough:peak ratio x 100%
|
114.45 trough:peak ratio x 100%
|
34.11 trough:peak ratio x 100%
|
71.00 trough:peak ratio x 100%
|
49.67 trough:peak ratio x 100%
|
44.50 trough:peak ratio x 100%
|
49.46 trough:peak ratio x 100%
|
59.47 trough:peak ratio x 100%
|
54.71 trough:peak ratio x 100%
|
52.86 trough:peak ratio x 100%
|
37.93 trough:peak ratio x 100%
|
41.95 trough:peak ratio x 100%
|
53.54 trough:peak ratio x 100%
|
52.07 trough:peak ratio x 100%
|
SECONDARY outcome
Timeframe: Weeks 1 through 48Refer to Adverse Event section for safety information.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Morning BP, Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=32 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM
Change in Morning SBP from Baseline to Week 6
|
-9.37 mmHg
Standard Deviation 9.564
|
-14.53 mmHg
Standard Deviation 17.166
|
-10.76 mmHg
Standard Deviation 9.112
|
-6.23 mmHg
Standard Deviation 9.159
|
-10.42 mmHg
Standard Deviation 8.815
|
-13.70 mmHg
Standard Deviation 10.056
|
-13.89 mmHg
Standard Deviation 12.288
|
-10.22 mmHg
Standard Deviation 12.734
|
-14.50 mmHg
Standard Deviation 12.031
|
-12.78 mmHg
Standard Deviation 14.700
|
-14.29 mmHg
Standard Deviation 14.136
|
-14.84 mmHg
Standard Deviation 13.383
|
-17.09 mmHg
Standard Deviation 13.194
|
-14.52 mmHg
Standard Deviation 15.111
|
-17.12 mmHg
Standard Deviation 14.016
|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM
Change in Morning DBP from Baseline to Week 6
|
-6.12 mmHg
Standard Deviation 8.457
|
-9.20 mmHg
Standard Deviation 10.516
|
-7.62 mmHg
Standard Deviation 8.033
|
-5.01 mmHg
Standard Deviation 7.141
|
-6.82 mmHg
Standard Deviation 6.279
|
-7.53 mmHg
Standard Deviation 8.206
|
-9.21 mmHg
Standard Deviation 9.474
|
-7.86 mmHg
Standard Deviation 8.416
|
-10.04 mmHg
Standard Deviation 8.489
|
-8.79 mmHg
Standard Deviation 10.902
|
-11.15 mmHg
Standard Deviation 10.411
|
-9.96 mmHg
Standard Deviation 10.730
|
-11.95 mmHg
Standard Deviation 8.060
|
-10.71 mmHg
Standard Deviation 11.012
|
-12.46 mmHg
Standard Deviation 8.763
|
SECONDARY outcome
Timeframe: Afternoon BP, Baseline, Week 6Population: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM
Change in Afternoon SBP from Baseline to Week 6
|
-9.68 mmHg
Standard Deviation 11.399
|
-17.21 mmHg
Standard Deviation 19.772
|
-10.53 mmHg
Standard Deviation 13.359
|
-9.69 mmHg
Standard Deviation 10.094
|
-13.34 mmHg
Standard Deviation 9.669
|
-13.76 mmHg
Standard Deviation 11.796
|
-13.96 mmHg
Standard Deviation 13.128
|
-15.54 mmHg
Standard Deviation 13.503
|
-16.38 mmHg
Standard Deviation 13.285
|
-14.51 mmHg
Standard Deviation 13.433
|
-17.97 mmHg
Standard Deviation 14.622
|
-17.82 mmHg
Standard Deviation 13.042
|
-20.91 mmHg
Standard Deviation 13.704
|
-20.46 mmHg
Standard Deviation 17.611
|
-19.36 mmHg
Standard Deviation 14.893
|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM
Change in Afternoon DBP from Baseline to Week 6
|
-5.62 mmHg
Standard Deviation 7.969
|
-10.25 mmHg
Standard Deviation 12.250
|
-6.67 mmHg
Standard Deviation 7.800
|
-6.27 mmHg
Standard Deviation 8.910
|
-10.12 mmHg
Standard Deviation 6.555
|
-8.38 mmHg
Standard Deviation 7.787
|
-11.28 mmHg
Standard Deviation 8.998
|
-12.04 mmHg
Standard Deviation 8.132
|
-11.59 mmHg
Standard Deviation 10.112
|
-12.18 mmHg
Standard Deviation 9.905
|
-14.03 mmHg
Standard Deviation 9.425
|
-12.54 mmHg
Standard Deviation 8.893
|
-15.12 mmHg
Standard Deviation 8.437
|
-13.87 mmHg
Standard Deviation 12.997
|
-15.02 mmHg
Standard Deviation 9.197
|
SECONDARY outcome
Timeframe: Night BP, Baseline, Week 6Population: : ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population
Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.
Outcome measures
| Measure |
Lisinopril 10
n=29 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=30 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=38 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=27 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=34 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=33 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=35 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=37 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=34 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=32 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=35 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=34 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=28 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=33 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=34 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM
Change in Night SBP from Baseline to Week 6
|
-9.01 mmHg
Standard Deviation 10.635
|
-11.58 mmHg
Standard Deviation 16.103
|
-10.38 mmHg
Standard Deviation 8.600
|
-4.28 mmHg
Standard Deviation 8.018
|
-7.70 mmHg
Standard Deviation 10.178
|
-7.71 mmHg
Standard Deviation 9.627
|
-10.37 mmHg
Standard Deviation 11.517
|
-9.94 mmHg
Standard Deviation 11.220
|
-12.64 mmHg
Standard Deviation 11.301
|
-10.02 mmHg
Standard Deviation 10.256
|
-11.87 mmHg
Standard Deviation 12.031
|
-11.25 mmHg
Standard Deviation 11.462
|
-12.08 mmHg
Standard Deviation 9.486
|
-14.12 mmHg
Standard Deviation 12.151
|
-13.06 mmHg
Standard Deviation 10.651
|
|
Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM
Change in Night DBP from Baseline to Week 6
|
-5.83 mmHg
Standard Deviation 6.602
|
-6.78 mmHg
Standard Deviation 8.251
|
-7.49 mmHg
Standard Deviation 6.085
|
-3.20 mmHg
Standard Deviation 5.340
|
-6.49 mmHg
Standard Deviation 5.723
|
-5.34 mmHg
Standard Deviation 7.187
|
-8.11 mmHg
Standard Deviation 7.260
|
-7.03 mmHg
Standard Deviation 6.853
|
-9.36 mmHg
Standard Deviation 7.068
|
-8.23 mmHg
Standard Deviation 7.458
|
-9.34 mmHg
Standard Deviation 8.960
|
-9.09 mmHg
Standard Deviation 7.321
|
-8.27 mmHg
Standard Deviation 6.002
|
-9.88 mmHg
Standard Deviation 8.161
|
-10.14 mmHg
Standard Deviation 7.468
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.
Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration
Outcome measures
| Measure |
Lisinopril 10
n=42 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=41 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=42 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=40 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=40 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=40 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=41 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=42 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=43 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=42 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=43 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=40 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=39 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=43 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=41 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment
Change in sSBP by Cuff from Baseline to Week 6
|
-11.97 mmHg
Standard Deviation 13.671
|
-10.85 mmHg
Standard Deviation 12.975
|
-13.09 mmHg
Standard Deviation 10.200
|
-5.68 mmHg
Standard Deviation 10.074
|
-5.07 mmHg
Standard Deviation 15.610
|
-8.88 mmHg
Standard Deviation 15.179
|
-9.54 mmHg
Standard Deviation 14.373
|
-11.84 mmHg
Standard Deviation 16.943
|
-13.43 mmHg
Standard Deviation 15.279
|
-9.79 mmHg
Standard Deviation 14.481
|
-11.26 mmHg
Standard Deviation 15.056
|
-13.49 mmHg
Standard Deviation 17.626
|
-6.42 mmHg
Standard Deviation 16.409
|
-9.00 mmHg
Standard Deviation 14.541
|
-14.58 mmHg
Standard Deviation 16.176
|
|
Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment
Change in sDBP by Cuff from Baseline to Week 6
|
-7.45 mmHg
Standard Deviation 13.671
|
-5.32 mmHg
Standard Deviation 8.969
|
-10.35 mmHg
Standard Deviation 7.627
|
-6.87 mmHg
Standard Deviation 5.671
|
-5.70 mmHg
Standard Deviation 9.760
|
-7.54 mmHg
Standard Deviation 8.469
|
-5.66 mmHg
Standard Deviation 8.949
|
-10.02 mmHg
Standard Deviation 10.384
|
-10.28 mmHg
Standard Deviation 8.543
|
-8.73 mmHg
Standard Deviation 10.771
|
-10.89 mmHg
Standard Deviation 10.757
|
-9.63 mmHg
Standard Deviation 11.073
|
-8.22 mmHg
Standard Deviation 9.203
|
-9.45 mmHg
Standard Deviation 11.204
|
-10.95 mmHg
Standard Deviation 8.624
|
SECONDARY outcome
Timeframe: Week 6Population: ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.
Outcome measures
| Measure |
Lisinopril 10
n=42 Participants
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
n=41 Participants
lisinopril 20 mg once daily
|
Lisinopril 40
n=42 Participants
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
n=40 Participants
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
n=40 Participants
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
n=40 Participants
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
n=41 Participants
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
n=42 Participants
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
n=43 Participants
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
n=42 Participants
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
n=43 Participants
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
n=40 Participants
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
n=39 Participants
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
n=43 Participants
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
n=41 Participants
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)
|
22 participants
|
23 participants
|
27 participants
|
20 participants
|
18 participants
|
17 participants
|
20 participants
|
28 participants
|
25 participants
|
30 participants
|
22 participants
|
27 participants
|
28 participants
|
24 participants
|
28 participants
|
Adverse Events
Lisinopril 10
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Lisinopril 20
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Lisinopril 40
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Carvedilol Controlled Release 20
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Carvedilol Controlled Release 40
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Carvedilol Controlled Release 80
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Carvedilol Controlled Release 20 Lisinopril 10
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Carvedilol Controlled Release 20 Lisinopril 20
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Carvedilol Controlled Release 20 Lisinopril 40
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Carvedilol Controlled Release 40 Lisinopril 10
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Carvedilol Controlled Release 40 Lisinopril 20
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Carvedilol Controlled Release 40 Lisinopril 40
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Carvedilol Controlled Release 80 Lisinopril 10
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Carvedilol Controlled Release 80 Lisinopril 20
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Carvedilol Controlled Release 80 Lisinopril 40
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lisinopril 10
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
lisinopril 20 mg once daily
|
Lisinopril 40
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Investigations
Blood pressure increased
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture (C2)
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
General disorders
Chest pain
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Psychiatric disorders
Depression
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Nervous system disorders
Headache
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Vascular disorders
Hypertension (worsening)
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Cardiac disorders
Left bundle branch block
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Psychiatric disorders
Listless
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
Other adverse events
| Measure |
Lisinopril 10
lisinopril 10 milligrams (mg) once daily
|
Lisinopril 20
lisinopril 20 mg once daily
|
Lisinopril 40
lisinopril 40 mg once daily
|
Carvedilol Controlled Release 20
carvedilol controlled release (CR) 20 mg once daily
|
Carvedilol Controlled Release 40
carvedilol CR 40 mg once daily
|
Carvedilol Controlled Release 80
carvedilol CR 80 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 10
carvedilol CR 20 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 20
carvedilol CR 20 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 20 Lisinopril 40
carvedilol CR 20 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 10
carvedilol CR 40 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 20
carvedilol CR 40 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 40 Lisinopril 40
carvedilol CR 40 mg plus lisinopril 40 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 10
carvedilol CR 80 mg plus lisinopril 10 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 20
carvedilol CR 80 mg plus lisinopril 20 mg once daily
|
Carvedilol Controlled Release 80 Lisinopril 40
carvedilol CR 80 mg plus lisinopril 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
16.3%
7/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
16.3%
7/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.6%
5/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.3%
4/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.4%
5/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
15.9%
7/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.8%
2/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Nervous system disorders
Dizziness
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.3%
4/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
13.6%
6/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.4%
5/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
6/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
15.9%
7/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.9%
5/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.8%
2/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
General disorders
Fatigue
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
15.9%
7/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.8%
2/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Gastrointestinal disorders
Nausea
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.8%
2/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.8%
2/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.4%
5/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Infections and infestations
Influenza
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.5%
2/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.1%
3/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
11.4%
5/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
4.7%
2/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
9.1%
4/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.3%
1/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
6.8%
3/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
2.4%
1/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
7.0%
3/43
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/44
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
0.00%
0/42
SAE/AE summary is based on the safety population, which comprised all randomized participants who received at least one dose of study medication; thus, the number of participants at risk differs by 1 for the Lis 20, Carv 40, Carv 40/Lis 40, and Carv 80/40 groups between the AE/SAE summary and the Participant Flow (all randomized participants).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the Publication of results from all centers of a multi-center trial but requests that reports based on Single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER