Trial Outcomes & Findings for An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION]) (NCT NCT01079962)
NCT ID: NCT01079962
Last Updated: 2014-02-13
Results Overview
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
209 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2014-02-13
Participant Flow
A total of 228 participants were screened for the study, out of which 19 were screen failures and 209 participants received the study medication.
Participant milestones
| Measure |
Bisoprolol
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
|
Overall Study
COMPLETED
|
90
|
89
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Bisoprolol
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
No blood pressure (BP) control
|
3
|
0
|
|
Overall Study
Inclusion/exclusion criteria
|
1
|
3
|
|
Overall Study
Participant not returning for next visit
|
1
|
0
|
|
Overall Study
Due to arrhythmia/bradycardia
|
1
|
1
|
Baseline Characteristics
An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
Baseline characteristics by cohort
| Measure |
Bisoprolol
n=105 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=104 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
52.2 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
52.2 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12
Baseline (n=96, 95)
|
47.49 Millimeter of mercury (mmHg)
Standard Deviation 11.33
|
45.93 Millimeter of mercury (mmHg)
Standard Deviation 11.62
|
|
Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12
Change in APP at Week 12 (n=90, 89)
|
-4.40 Millimeter of mercury (mmHg)
Standard Deviation 9.29
|
-3.69 Millimeter of mercury (mmHg)
Standard Deviation 8.86
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.
Outcome measures
| Measure |
Bisoprolol
n=85 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=89 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12
Baseline
|
46.87 mmHg
Standard Deviation 11.34
|
46.53 mmHg
Standard Deviation 11.66
|
|
Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12
Change in APP at Week 12
|
-4.33 mmHg
Standard Deviation 9.66
|
-3.89 mmHg
Standard Deviation 9.07
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
The change in aortic BP (aortic systolic blood pressure \[SBP\], aortic diastolic blood pressure \[DBP\] and aortic mean blood pressure \[BP\]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic SBP at Week 4 (n=96, 95)
|
-13.90 mmHg
Standard Deviation 12.68
|
-13.57 mmHg
Standard Deviation 12.73
|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic SBP at Week 12 (n=90, 89)
|
-15.34 mmHg
Standard Deviation 15.11
|
-12.71 mmHg
Standard Deviation 14.67
|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic DBP at Week 4 (n=96, 95)
|
-10.86 mmHg
Standard Deviation 8.23
|
-9.47 mmHg
Standard Deviation 8.23
|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic DBP at Week 12 (n=90, 89)
|
-10.94 mmHg
Standard Deviation 9.53
|
-9.01 mmHg
Standard Deviation 8.79
|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic mean BP at Week 4 (n=96, 95)
|
-11.88 mmHg
Standard Deviation 8.60
|
-10.84 mmHg
Standard Deviation 9.07
|
|
Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12
Change in aortic mean BP at Week 12 (n=90, 89)
|
-12.41 mmHg
Standard Deviation 10.84
|
-10.24 mmHg
Standard Deviation 10.28
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12
Change in AIx at Week 4 (n=96, 95)
|
-1.56 Ratio
Standard Deviation 10.43
|
-0.01 Ratio
Standard Deviation 10.14
|
|
Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12
Change in AIx at Week 12 (n=90, 89)
|
0.61 Ratio
Standard Deviation 9.18
|
1.21 Ratio
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12
Change in cfPWV at Week 4 (n=96, 95)
|
-0.60 Meters per second (m/s)
Standard Deviation 1.33
|
-0.81 Meters per second (m/s)
Standard Deviation 1.15
|
|
Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12
Change cfPWV at Week 12 (n=90, 89)
|
-0.72 Meters per second (m/s)
Standard Deviation 1.40
|
-0.87 Meters per second (m/s)
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Heart Rate at Week 4 and Week 12
Change in heart rate at Week 4 (n= 96, 95)
|
-6.21 Beats per minute (bpm)
Standard Deviation 7.72
|
-6.20 Beats per minute (bpm)
Standard Deviation 8.25
|
|
Change From Baseline in Heart Rate at Week 4 and Week 12
Change heart rate at Week 12 (n= 90, 89)
|
-8.64 Beats per minute (bpm)
Standard Deviation 7.95
|
-7.84 Beats per minute (bpm)
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Aortic Pulse Pressure (APP) at Week 4
|
-3.02 mmHg
Standard Deviation 10.56
|
-4.09 mmHg
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Lipid Levels at Week 12
Change in Total cholesterol at Week 12
|
-3.43 Milligram/decilitre (mg/dL)
Standard Deviation 23.35
|
-0.37 Milligram/decilitre (mg/dL)
Standard Deviation 24.79
|
|
Change From Baseline in Lipid Levels at Week 12
Change in LDL-cholesterol at Week 12
|
-2.29 Milligram/decilitre (mg/dL)
Standard Deviation 19.01
|
1.31 Milligram/decilitre (mg/dL)
Standard Deviation 17.77
|
|
Change From Baseline in Lipid Levels at Week 12
Change in HDL-cholesterol at Week 12
|
-1.58 Milligram/decilitre (mg/dL)
Standard Deviation 7.13
|
-3.02 Milligram/decilitre (mg/dL)
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.
Outcome measures
| Measure |
Bisoprolol
n=90 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=89 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Levels at Week 12
|
-0.23 Millimoles per liter (mmol/L)
Standard Deviation 17.85
|
-0.45 Millimoles per liter (mmol/L)
Standard Deviation 12.03
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. "n" signifies those participants who were evaluated for this measure at the specified time point.
The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.
Outcome measures
| Measure |
Bisoprolol
n=96 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=95 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial SBP at Week 4 (n=96, 95)
|
-17.45 mmHg
Standard Deviation 11.74
|
-17.52 mmHg
Standard Deviation 12.53
|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial SBP at Week 12 (n=90, 89)
|
-19.10 mmHg
Standard Deviation 14.55
|
-17.63 mmHg
Standard Deviation 13.74
|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial DBP at Week 4 (n=96, 95)
|
-12.70 mmHg
Standard Deviation 9.01
|
-11.36 mmHg
Standard Deviation 8.34
|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial DBP at Week 12 (n=90, 89)
|
-13.39 mmHg
Standard Deviation 9.90
|
-10.61 mmHg
Standard Deviation 8.79
|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial mean BP at Week 4 (n=96, 95)
|
-14.28 mmHg
Standard Deviation 9.28
|
-13.41 mmHg
Standard Deviation 8.94
|
|
Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12
Change in brachial mean BP at Week 12 (n=90, 89)
|
-15.29 mmHg
Standard Deviation 10.78
|
-12.95 mmHg
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: Baseline up to Week 14 (follow-up visit)Population: ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
Bisoprolol
n=105 Participants
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=104 Participants
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
36 Participants
|
32 Participants
|
Adverse Events
Bisoprolol
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Atenolol
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bisoprolol
n=105 participants at risk
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=104 participants at risk
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
General disorders
Concussion
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.9%
2/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine carcinoma
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Coronary artery disorder
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache aggravated
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness aggravated
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Bisoprolol
n=105 participants at risk
Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
|
Atenolol
n=104 participants at risk
Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic atopic
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Liver fatty
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.9%
2/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia aggravated
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Pain neck/shoulder
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Cartilage damage
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyperlipaemia
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Common cold
|
1.9%
2/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.8%
6/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Bronchitis
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Herpes zoster
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Cystitis
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Tinea
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Upper respiratory tract infection
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.9%
2/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Otitis media
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Reproductive system and breast disorders
Impotence
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Dry eyes
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine fibromyoma
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
AV block first degree
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Sinus bradycardia
|
2.9%
3/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
3.8%
4/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Bradyarrhythmia
|
1.9%
2/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Cardiomegaly
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Bladder irritability
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Ureteral calculus
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Polyposis gastric
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Anaemia
|
1.9%
2/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest tightness of
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest discomfort
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.9%
2/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest pressure sensation of
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chest pain
|
3.8%
4/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Oedema
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pain groin
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Face oedema
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Hot flushes
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pain in limb
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.9%
2/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
1.9%
2/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Sleepiness
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Paraesthesia
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Eyelid fluttering
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
2.9%
3/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache aggravated
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Radiculopathy cervical
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
7.6%
8/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
5.8%
6/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.9%
2/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.96%
1/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin cysts
|
0.95%
1/105 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/104 • Baseline up to Week 14 (follow-up visit)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER