Trial Outcomes & Findings for Patient Convenience Study (RE-SONANCE) (NCT NCT02684981)
NCT ID: NCT02684981
Last Updated: 2019-07-24
Results Overview
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Recruitment status
COMPLETED
Target enrollment
9472 participants
Primary outcome timeframe
From baseline up to 210 days
Results posted on
2019-07-24
Participant Flow
This is an observational study. Total 9472 patients with Non-Valvular Atrial Fibrillation (NVAF) were enrolled in the study using Vitamin K antagonist (VKA) therapy prior to being switched to Pradaxa® and newly diagnosed with NVAF and initiated Pradaxa® or VKA. Patients were followed up for observational period of approximately 6 months.
All patients were screened for eligibility. All enrolled patients met all implemented inclusion/exclusion criteria. Out of 9472 enrolled patients, 7 patients with unknown study treatment were not included in the main analysis set. Total 9465 patients were included in the main analysis set and started the study.
Participant milestones
| Measure |
Cohort A
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- Pradaxa®
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4100
|
3179
|
2186
|
|
Overall Study
COMPLETED
|
3860
|
2969
|
2059
|
|
Overall Study
NOT COMPLETED
|
240
|
210
|
127
|
Reasons for withdrawal
| Measure |
Cohort A
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- Pradaxa®
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Overall Study
Permanently discontinued the treatment
|
157
|
161
|
110
|
|
Overall Study
Other
|
83
|
49
|
17
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- Pradaxa®
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Total
n=9465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.5 Years
STANDARD_DEVIATION 9.57 • n=4100 Participants
|
68.6 Years
STANDARD_DEVIATION 10.1 • n=3179 Participants
|
68.5 Years
STANDARD_DEVIATION 9.49 • n=2186 Participants
|
69.4 Years
STANDARD_DEVIATION 9.79 • n=9465 Participants
|
|
Sex: Female, Male
Female
|
1998 Participants
n=4100 Participants
|
1602 Participants
n=3179 Participants
|
1080 Participants
n=2186 Participants
|
4680 Participants
n=9465 Participants
|
|
Sex: Female, Male
Male
|
2102 Participants
n=4100 Participants
|
1577 Participants
n=3179 Participants
|
1106 Participants
n=2186 Participants
|
4785 Participants
n=9465 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From baseline up to 210 daysPopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Median change from V1 to V2
|
19.23 Unit on scale
Interval -67.3 to 86.5
|
—
|
—
|
|
Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Median change from V1 to V3
|
23.08 Unit on scale
Interval -82.7 to 92.3
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline up to 210 daysPopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Median change from V1 to V2
|
17.86 Unit on scale
Interval -85.7 to 78.6
|
—
|
—
|
|
Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Median change from V1 to V3
|
21.43 Unit on scale
Interval -57.1 to 85.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 up to Day 210Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Outcome measures
| Measure |
Cohort A
n=3179 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
V2
|
82.69 Unit on scale
Interval 0.0 to 100.0
|
50.00 Unit on scale
Interval 3.8 to 100.0
|
—
|
|
Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
V3
|
86.54 Unit on scale
Interval 15.4 to 100.0
|
59.62 Unit on scale
Interval 0.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Day 30 up to Day 210Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Outcome measures
| Measure |
Cohort A
n=3179 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
V2
|
67.86 Unit on scale
Interval 0.0 to 100.0
|
50.00 Unit on scale
Interval 0.0 to 100.0
|
—
|
|
Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
V3
|
71.43 Unit on scale
Interval 17.9 to 100.0
|
50.00 Unit on scale
Interval 0.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. Score of \< 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
High risk (Score >= 2)
|
88.3 Percentage of patients (%)
|
87.8 Percentage of patients (%)
|
91.4 Percentage of patients (%)
|
|
Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
Low risk (Score < 2)
|
5.4 Percentage of patients (%)
|
8.2 Percentage of patients (%)
|
7.0 Percentage of patients (%)
|
|
Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
Data not available
|
6.3 Percentage of patients (%)
|
4.0 Percentage of patients (%)
|
1.6 Percentage of patients (%)
|
PRIMARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation. A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2. A high score corresponds to a greater risk, while low score corresponds to a lower risk. Data presented are percentage of patients with high and low risk.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
High risk (Score >= 3)
|
59.2 Percentage of patients (%)
|
29.1 Percentage of patients (%)
|
31.3 Percentage of patients (%)
|
|
Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
Low risk (Score < 3)
|
31.0 Percentage of patients (%)
|
64.8 Percentage of patients (%)
|
65.7 Percentage of patients (%)
|
|
Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
Data not available
|
9.7 Percentage of patients (%)
|
6.8 Percentage of patients (%)
|
2.9 Percentage of patients (%)
|
PRIMARY outcome
Timeframe: Baseline and up to 210 daysPopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Creatinine is filtered from the blood by the kidneys and released into the urine. A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection. The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine. Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
V1
|
73.89 millilitre per minute (mL/min)
Interval 73.02 to 74.77
|
76.24 millilitre per minute (mL/min)
Interval 75.25 to 77.24
|
71.83 millilitre per minute (mL/min)
Interval 70.63 to 73.04
|
|
Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
V2
|
74.59 millilitre per minute (mL/min)
Interval 73.17 to 76.05
|
75.27 millilitre per minute (mL/min)
Interval 73.71 to 76.86
|
71.86 millilitre per minute (mL/min)
Interval 69.87 to 73.89
|
|
Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
V3
|
72.82 millilitre per minute (mL/min)
Interval 71.61 to 74.05
|
74.24 millilitre per minute (mL/min)
Interval 72.81 to 75.69
|
71.79 millilitre per minute (mL/min)
Interval 69.98 to 73.63
|
PRIMARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. Data presented here are percentage of total patients with comorbidities.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Comorbidities
|
86.4 Percentage of patients (%)
|
83.4 Percentage of patients (%)
|
90.9 Percentage of patients (%)
|
PRIMARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
Concomitant therapies are two or more drugs used or given at or almost at the same time. The data presented here are percentage of total patients for taking concomitant medication.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Concomitant Therapies
|
86.4 Percentage of patients (%)
|
83.4 Percentage of patients (%)
|
91.2 Percentage of patients (%)
|
PRIMARY outcome
Timeframe: Baseline and up to 210 daysPopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=3179 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Characterization of Patients With Respect to Dosing of Pradaxa
Pradaxa 110 mg at V1
|
34.9 Percentage of patients (%)
|
30.4 Percentage of patients (%)
|
—
|
|
Characterization of Patients With Respect to Dosing of Pradaxa
Pradaxa 150 mg at V1
|
65.1 Percentage of patients (%)
|
69.6 Percentage of patients (%)
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Duration in Months of Previous VKA Treatment
|
34.00 Months
Standard Deviation 39.93
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Treated set (Necessary data was not collected in the data base)
This endpoint is not assessable as the necessary data was not collected in the database
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 30 days up to 210 daysPopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).
Outcome measures
| Measure |
Cohort A
n=4100 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Convenience PACT-Q2
|
1.92 Unit on scale
Interval -80.8 to 82.7
|
—
|
—
|
|
PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Satisfaction PACT-Q2
|
3.57 Unit on scale
Interval -57.1 to 85.7
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information
Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy. Following are the seven items from PACT-Q1. The score range is 1-5. Each question is analyzed individually, with higher score indicating better outcome. A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots? A2 - Do you expect that your AT will relieve some of the symptoms you experience? A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding? A4 - How important is it for you to have an AT that is easy to take? A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself? A7 - How concerned are you about how much you may have to pay for your AT? For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.
Outcome measures
| Measure |
Cohort A
n=3179 Participants
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- VKA
n=2186 Participants
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B- VKA
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|
|
Description of PACT-Q1 Items at Baseline
A1- Not at all
|
2.0 Percentage of patients (%)
|
3.1 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A1- A lot
|
50.8 Percentage of patients (%)
|
43.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- Not at all
|
17.3 Percentage of patients (%)
|
11.3 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- Moderately
|
19.8 Percentage of patients (%)
|
27.6 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A1- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A1- A little
|
9.6 Percentage of patients (%)
|
13.0 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A1- Moderately
|
27.8 Percentage of patients (%)
|
31.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A1- Extremely
|
7.7 Percentage of patients (%)
|
6.1 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- Not at all
|
11.6 Percentage of patients (%)
|
11.8 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- A little
|
18.5 Percentage of patients (%)
|
23.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- Moderately
|
28.9 Percentage of patients (%)
|
31.2 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- A lot
|
30.9 Percentage of patients (%)
|
26.6 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A2- Extremely
|
7.9 Percentage of patients (%)
|
4.6 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- Not at all
|
17.8 Percentage of patients (%)
|
13.2 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- A little
|
38.4 Percentage of patients (%)
|
38.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- Moderately
|
26.9 Percentage of patients (%)
|
30.7 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- A lot
|
12.6 Percentage of patients (%)
|
12.0 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A3- Extremely
|
2.2 Percentage of patients (%)
|
2.6 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- Not at all
|
3.3 Percentage of patients (%)
|
2.7 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- A little
|
5.6 Percentage of patients (%)
|
7.3 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- Moderately
|
16.4 Percentage of patients (%)
|
20.5 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- A lot
|
56.1 Percentage of patients (%)
|
53.0 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A4- Extremely
|
16.5 Percentage of patients (%)
|
14.1 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- A little
|
25.3 Percentage of patients (%)
|
23.0 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- A lot
|
27.2 Percentage of patients (%)
|
27.5 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A5- Extremely
|
8.2 Percentage of patients (%)
|
8.3 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- Not at all
|
3.7 Percentage of patients (%)
|
3.2 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- A little
|
7.9 Percentage of patients (%)
|
7.8 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- Moderately
|
17.3 Percentage of patients (%)
|
24.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- A lot
|
52.6 Percentage of patients (%)
|
49.8 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A6- Extremely
|
16.3 Percentage of patients (%)
|
11.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- Missing
|
2.2 Percentage of patients (%)
|
2.4 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- Not at all
|
11.4 Percentage of patients (%)
|
8.8 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- A little
|
14.8 Percentage of patients (%)
|
11.1 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- Moderately
|
31.0 Percentage of patients (%)
|
20.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- A lot
|
26.2 Percentage of patients (%)
|
36.9 Percentage of patients (%)
|
—
|
|
Description of PACT-Q1 Items at Baseline
A7- Extremely
|
14.4 Percentage of patients (%)
|
20.0 Percentage of patients (%)
|
—
|
Adverse Events
Cohort A
Serious events: 26 serious events
Other events: 0 other events
Deaths: 5 deaths
Cohort B- Pradaxa®
Serious events: 25 serious events
Other events: 0 other events
Deaths: 2 deaths
Cohort B- VKA
Serious events: 15 serious events
Other events: 0 other events
Deaths: 4 deaths
Cohort B
Serious events: 40 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort A
n=4066 participants at risk
Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included.
|
Cohort B- Pradaxa®
n=3164 participants at risk
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy.
|
Cohort B- VKA
n=2181 participants at risk
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included.
|
Cohort B
n=5345 participants at risk
Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) or Vitamin K Antagonist (VKA) therapy were included.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.04%
2/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.09%
2/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
3/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Cardiac arrest
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Cardiac failure
|
0.07%
3/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
2/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
3/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.07%
3/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
2/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.09%
2/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.07%
4/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Ileus
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
General disorders
Asthenia
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
General disorders
Chest discomfort
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
General disorders
Chest pain
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.04%
2/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
General disorders
Death
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
2/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.14%
3/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.09%
5/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
General disorders
Sudden death
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Infections and infestations
Erysipelas
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Infections and infestations
Pneumonia
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Investigations
Blood creatinine increased
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Dizziness
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.07%
3/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.13%
4/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.09%
5/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.06%
2/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.04%
2/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.05%
2/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Left atrial appendage occlusion
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Meningioma surgery
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Surgical and medical procedures
Vascular stent insertion
|
0.02%
1/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.03%
1/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4066 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.00%
0/3164 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.05%
1/2181 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
0.02%
1/5345 • From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place