Trial Outcomes & Findings for RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome (NCT NCT00621855)
NCT ID: NCT00621855
Last Updated: 2014-03-12
Results Overview
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1878 participants
Primary outcome timeframe
6 month treatment period + 2 week post treatment follow up
Results posted on
2014-03-12
Participant Flow
International multi-centre trial with 161 trial sites in 24 countries recruiting patients with acute coronary syndromes with increased troponin levels within 14 days post index myocardial infarction (ST or non-ST elevation between March 2008 and March 2009.
Patients receiving aspirin and clopidogrel at randomisation were included. They also had at least 1 additional risk factor (for e.g. age ≥65 years, diabetes previous myocardial infarction, peripheral arterial disease). Moderate renal impairment at screening resulted in dose adjustment.
Participant milestones
| Measure |
50mg Dabigatran Etexilate
26 week blinded treatment
|
75mg Dabigatran Etexilate
26 week blinded treatment
|
110mg Dabigatran Etexilate
26 week blinded treatment
|
150mg Dabigatran Etexilate
26 week blinded treatment
|
Placebo
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
372
|
371
|
411
|
351
|
373
|
|
Overall Study
COMPLETED
|
296
|
310
|
330
|
284
|
318
|
|
Overall Study
NOT COMPLETED
|
76
|
61
|
81
|
67
|
55
|
Reasons for withdrawal
| Measure |
50mg Dabigatran Etexilate
26 week blinded treatment
|
75mg Dabigatran Etexilate
26 week blinded treatment
|
110mg Dabigatran Etexilate
26 week blinded treatment
|
150mg Dabigatran Etexilate
26 week blinded treatment
|
Placebo
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
32
|
31
|
48
|
34
|
31
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
4
|
1
|
|
Overall Study
Protocol Violation
|
16
|
8
|
6
|
7
|
8
|
|
Overall Study
Withdrawal by Subject
|
16
|
11
|
13
|
13
|
9
|
|
Overall Study
Other
|
9
|
7
|
6
|
5
|
4
|
|
Overall Study
Patients did not receive study drug
|
3
|
3
|
5
|
4
|
2
|
Baseline Characteristics
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
50mg Dabigatran Etexilate
n=372 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=371 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=411 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=351 Participants
26 week blinded treatment
|
Placebo
n=373 Participants
26 week blinded treatment
|
Total
n=1878 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
62.3 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
61.5 Years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
61.8 Years
STANDARD_DEVIATION 11.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
450 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
288 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
292 Participants
n=21 Participants
|
1428 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
288 participants
n=5 Participants
|
267 participants
n=7 Participants
|
324 participants
n=5 Participants
|
300 participants
n=4 Participants
|
268 participants
n=21 Participants
|
1447 participants
n=10 Participants
|
|
Race (NIH/OMB)
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
84 participants
n=5 Participants
|
102 participants
n=7 Participants
|
82 participants
n=5 Participants
|
51 participants
n=4 Participants
|
105 participants
n=21 Participants
|
424 participants
n=10 Participants
|
|
Race (NIH/OMB)
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
6 participants
n=10 Participants
|
|
Region of Enrollment
Central Europe
|
165 participants
n=5 Participants
|
155 participants
n=7 Participants
|
230 participants
n=5 Participants
|
217 participants
n=4 Participants
|
165 participants
n=21 Participants
|
932 participants
n=10 Participants
|
|
Region of Enrollment
Western Europe
|
98 participants
n=5 Participants
|
93 participants
n=7 Participants
|
79 participants
n=5 Participants
|
72 participants
n=4 Participants
|
84 participants
n=21 Participants
|
426 participants
n=10 Participants
|
|
Region of Enrollment
Asia
|
84 participants
n=5 Participants
|
99 participants
n=7 Participants
|
81 participants
n=5 Participants
|
51 participants
n=4 Participants
|
104 participants
n=21 Participants
|
419 participants
n=10 Participants
|
|
Region of Enrollment
North America
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
11 participants
n=4 Participants
|
20 participants
n=21 Participants
|
101 participants
n=10 Participants
|
|
Type of Index Event
ST elevation myocardial infarction (STEMI)
|
211 participants
n=5 Participants
|
227 participants
n=7 Participants
|
254 participants
n=5 Participants
|
204 participants
n=4 Participants
|
230 participants
n=21 Participants
|
1126 participants
n=10 Participants
|
|
Type of Index Event
Non ST elevation myocardial infarction (NSTEMI)
|
161 participants
n=5 Participants
|
144 participants
n=7 Participants
|
157 participants
n=5 Participants
|
147 participants
n=4 Participants
|
143 participants
n=21 Participants
|
752 participants
n=10 Participants
|
|
Creatinine Clearance N=(372;371;411;350;373;1877)
|
85.4 mL/min
STANDARD_DEVIATION 30.2 • n=5 Participants
|
88.7 mL/min
STANDARD_DEVIATION 32.4 • n=7 Participants
|
84.7 mL/min
STANDARD_DEVIATION 32 • n=5 Participants
|
86.3 mL/min
STANDARD_DEVIATION 28.1 • n=4 Participants
|
86.6 mL/min
STANDARD_DEVIATION 34.8 • n=21 Participants
|
86.3 mL/min
STANDARD_DEVIATION 31.6 • n=10 Participants
|
PRIMARY outcome
Timeframe: 6 month treatment period + 2 week post treatment follow upPopulation: Treated set - The treated set includes all patients who received at least one dose of study medication.
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=369 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 Participants
26 week blinded treatment
|
Placebo
n=371 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
Major and clinically relevant minor bleed events
|
13 participants
|
16 participants
|
32 participants
|
27 participants
|
8 participants
|
|
Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time
No major or clinically relevant minor bleed events
|
356 participants
|
352 participants
|
374 participants
|
320 participants
|
363 participants
|
SECONDARY outcome
Timeframe: 6 month treatment period + 2 week post treatment follow upPopulation: Treated set
Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=369 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 Participants
26 week blinded treatment
|
Placebo
n=371 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment
CVD, non-fatal MI, non-haemorrhagic stroke
|
17 participants
|
18 participants
|
12 participants
|
12 participants
|
14 participants
|
|
Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment
ACD, non-fatal MI, SRI, non-haemorrhagic stroke
|
25 participants
|
27 participants
|
21 participants
|
25 participants
|
26 participants
|
SECONDARY outcome
Timeframe: 6 month treatment period + 2 week post treatment follow upPopulation: Treated set
Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=369 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 Participants
26 week blinded treatment
|
Placebo
n=371 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Cardiovascular death
|
8 participants
|
9 participants
|
5 participants
|
4 participants
|
9 participants
|
|
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Non-fatal myocardial infarction
|
9 participants
|
8 participants
|
7 participants
|
8 participants
|
4 participants
|
|
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Severe recurrent ischaemia
|
9 participants
|
11 participants
|
9 participants
|
11 participants
|
9 participants
|
|
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
Non-haemorrhagic stroke
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment
All cause death
|
8 participants
|
10 participants
|
7 participants
|
7 participants
|
14 participants
|
SECONDARY outcome
Timeframe: at 1 week and 4 weeksPopulation: Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=358 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=358 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=388 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=332 Participants
26 week blinded treatment
|
Placebo
n=356 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Number of Participants With Any Reduction of D-dimer Concentration
Number of Patients with any reduction
|
290 participants
|
293 participants
|
333 participants
|
296 participants
|
264 participants
|
|
Number of Participants With Any Reduction of D-dimer Concentration
Number of Patients with no reduction
|
48 participants
|
49 participants
|
41 participants
|
28 participants
|
77 participants
|
|
Number of Participants With Any Reduction of D-dimer Concentration
Missing data
|
20 participants
|
16 participants
|
14 participants
|
8 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline and at 1 week and 4 weeksPopulation: Full Analysis Set (FAS)
Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=358 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=358 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=388 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=332 Participants
26 week blinded treatment
|
Placebo
n=356 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Ratio of week 4 to baseline
|
0.33 ratio
Standard Deviation 3.04
|
0.31 ratio
Standard Deviation 3.30
|
0.29 ratio
Standard Deviation 3.14
|
0.31 ratio
Standard Deviation 3.02
|
0.57 ratio
Standard Deviation 3.01
|
|
Change From Baseline in log10 D-dimer After 1 and 4 Weeks
Ratio of week 1 to baseline
|
0.58 ratio
Standard Deviation 2.60
|
0.52 ratio
Standard Deviation 2.81
|
0.52 ratio
Standard Deviation 2.54
|
0.55 ratio
Standard Deviation 2.58
|
0.87 ratio
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: 6 month treatment period + 2 week post treatment follow upPopulation: Treated set
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=369 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 Participants
26 week blinded treatment
|
Placebo
n=371 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Number of Participants With Bleeding Events During Total Observation Time
Major bleeding events
|
3 participants
|
1 participants
|
8 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Bleeding Events During Total Observation Time
Clinically relevant bleeding events
|
10 participants
|
16 participants
|
24 participants
|
23 participants
|
6 participants
|
|
Number of Participants With Bleeding Events During Total Observation Time
Not clinically relevant bleeding events
|
32 participants
|
29 participants
|
35 participants
|
20 participants
|
17 participants
|
|
Number of Participants With Bleeding Events During Total Observation Time
Any bleeding events
|
42 participants
|
45 participants
|
60 participants
|
42 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 6 month treatment period + 2 week post treatment follow upPopulation: Treated set
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Outcome measures
| Measure |
50mg Dabigatran Etexilate
n=369 Participants
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 Participants
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 Participants
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 Participants
26 week blinded treatment
|
Placebo
n=371 Participants
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Laboratory Analyses
AST increase N=(359;359;388;329;356)
|
8 participants
|
5 participants
|
5 participants
|
2 participants
|
4 participants
|
|
Laboratory Analyses
AST decrease N=(359;359;388;329;356)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Laboratory Analyses
ALT increase N=(359;359;388;329;356)
|
10 participants
|
4 participants
|
4 participants
|
7 participants
|
4 participants
|
|
Laboratory Analyses
ALT decrease N=(359;359;388;329;356)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Laboratory Analyses
Bilirubin increase N=(359;360;388;329;355)
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Laboratory Analyses
Bilirubin decrease N=(359;360;388;329;355)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
50mg Dabigatran Etexilate
Serious events: 33 serious events
Other events: 0 other events
Deaths: 0 deaths
75mg Dabigatran Etexilate
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
110mg Dabigatran Etexilate
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
150mg Dabigatran Etexilate
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 32 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
50mg Dabigatran Etexilate
n=369 participants at risk
26 week blinded treatment
|
75mg Dabigatran Etexilate
n=368 participants at risk
26 week blinded treatment
|
110mg Dabigatran Etexilate
n=406 participants at risk
26 week blinded treatment
|
150mg Dabigatran Etexilate
n=347 participants at risk
26 week blinded treatment
|
Placebo
n=371 participants at risk
26 week blinded treatment
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
rectal cancer
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
small intestine carcinoma
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Nervous system disorders
dizziness
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
angina pectoris
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
1.1%
4/368 • Number of events 5 • 6 month treatment period + 3 days
|
0.74%
3/406 • Number of events 3 • 6 month treatment period + 3 days
|
0.58%
2/347 • Number of events 2 • 6 month treatment period + 3 days
|
1.3%
5/371 • Number of events 5 • 6 month treatment period + 3 days
|
|
Cardiac disorders
Unstable angina
|
1.1%
4/369 • Number of events 4 • 6 month treatment period + 3 days
|
1.1%
4/368 • Number of events 4 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
cardiac failure
|
0.54%
2/369 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
atrial fibrillation
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.54%
2/371 • Number of events 2 • 6 month treatment period + 3 days
|
|
Cardiac disorders
bradycardia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
acute cardiac failure
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
coronary artery stenosis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
acute LV failure
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
arteriosclerosis coronary artery
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
atrial flutter
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
1st degree AV block
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
congestive cardiac failure
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
cardiac tamponade
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
coronary artery disease
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.54%
2/371 • Number of events 2 • 6 month treatment period + 3 days
|
|
Cardiac disorders
coronary artery occlusion
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
coronary artery thrombosis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
LV failure
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
myocardial infarction
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
myocardial ischaemia
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
post infarct angina
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
ventricular extrasystoles
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Cardiac disorders
ventricular fibrillation
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
General disorders
chest pain
|
0.81%
3/369 • Number of events 3 • 6 month treatment period + 3 days
|
1.1%
4/368 • Number of events 5 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
General disorders
non cardiac chest pain
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.74%
3/406 • Number of events 3 • 6 month treatment period + 3 days
|
0.58%
2/347 • Number of events 2 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
General disorders
asthenia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
bacterial arthritis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
bronchitis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
infective cholecystitis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
diabetic gangrene
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
diverticuliitis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
erysipelas
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
lobar pneumonia
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
pneumonia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Infections and infestations
respiratory tract infection
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Vascular disorders
ischaemia
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
angiopathy
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
BP fluctuation
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
extremity necrosis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
hypertension
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Vascular disorders
peripheral ischaemia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.54%
2/368 • Number of events 2 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.58%
2/347 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
acute pulmonary oedema
|
0.27%
1/369 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
constipation
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
haemorrhoids
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
reflux oesophagitis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Gastrointestinal disorders
erosive gastritis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Hepatobiliary disorders
acute cholecystitis
|
0.54%
2/369 • Number of events 2 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Hepatobiliary disorders
bile duct stone
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Hepatobiliary disorders
cholecystitis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Hepatobiliary disorders
cholelithiasis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Hepatobiliary disorders
hydrocholecystis
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
acetabulum fracture
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
in stent coronary artery stenosis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
vascular pseudoaneurysm
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
lead dislodgement
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Metabolism and nutrition disorders
acidosis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Metabolism and nutrition disorders
inadequate control of diabetes mellitus
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.54%
2/371 • Number of events 2 • 6 month treatment period + 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cholesteatoma
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chronic lymphocytic leukaemia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic carcinoma
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Nervous system disorders
epilepsy
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Nervous system disorders
ischaemic stroke
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Nervous system disorders
syncope
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Nervous system disorders
hemianopia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Nervous system disorders
paraparesis
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Renal and urinary disorders
acute prerenal failure
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Renal and urinary disorders
acute renal failure
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.49%
2/406 • Number of events 2 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Blood and lymphatic system disorders
thrombocythaemia
|
0.27%
1/369 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.27%
1/368 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Psychiatric disorders
anxiety
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.25%
1/406 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/347 • 6 month treatment period + 3 days
|
0.27%
1/371 • Number of events 1 • 6 month treatment period + 3 days
|
|
Skin and subcutaneous tissue disorders
angioedema
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
|
Investigations
haemoglobin decrease
|
0.00%
0/369 • 6 month treatment period + 3 days
|
0.00%
0/368 • 6 month treatment period + 3 days
|
0.00%
0/406 • 6 month treatment period + 3 days
|
0.29%
1/347 • Number of events 1 • 6 month treatment period + 3 days
|
0.00%
0/371 • 6 month treatment period + 3 days
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER