Trial Outcomes & Findings for EVOLVE Short DAPT Study (NCT NCT02605447)

NCT ID: NCT02605447

Last Updated: 2020-09-25

Results Overview

Rate of death or myocardial infarction

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2009 participants

Primary outcome timeframe

3 to 15 months

Results posted on

2020-09-25

Participant Flow

There were 2009 subjects enrolled at 110 centers in USA, Japan, Germany, Sweden, Brazil, Latvia and Switzerland between 16 February 2016 and 30 March 2018.

2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.

Participant milestones

Participant milestones
Measure
SYNERGY Stent + 3 Month DAPT
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.
Overall Study
STARTED
1487
Overall Study
COMPLETED
1385
Overall Study
NOT COMPLETED
102

Reasons for withdrawal

Reasons for withdrawal
Measure
SYNERGY Stent + 3 Month DAPT
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.
Overall Study
Death
66
Overall Study
Physician Decision
1
Overall Study
Lost to Follow-up
24
Overall Study
Withdrawal by Subject
10
Overall Study
Not disclosed
1

Baseline Characteristics

EVOLVE Short DAPT Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SYNERGY Stent + 3 Month DAPT
n=1487 Participants
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Age, Continuous
75.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male
Female
506 Participants
n=5 Participants
Sex: Female, Male
Male
981 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
130 Participants
n=5 Participants
Race/Ethnicity, Customized
Black, African Heritage
70 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
1159 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
45 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaian or other Pacific Islander
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
14 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Disclosed
66 Participants
n=5 Participants
Region of Enrollment
Latvia
25 participants
n=5 Participants
Region of Enrollment
Sweden
21 participants
n=5 Participants
Region of Enrollment
United States
1177 participants
n=5 Participants
Region of Enrollment
Japan
117 participants
n=5 Participants
Region of Enrollment
Brazil
29 participants
n=5 Participants
Region of Enrollment
Switzerland
13 participants
n=5 Participants
Region of Enrollment
Germany
105 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 to 15 months

Population: 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Rate of death or myocardial infarction

Outcome measures

Outcome measures
Measure
SYNERGY Stent + 3 Month DAPT
n=1457 Participants
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Number of Participants Who Experienced Death or Myocardial Infarction (MI)
84 Participants

PRIMARY outcome

Timeframe: 3 to 15 months

Population: 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days.

Outcome measures

Outcome measures
Measure
SYNERGY Stent + 3 Month DAPT
n=1457 Participants
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Number of Participants Who Experienced Stent Thrombosis (ST)
3 Participants

SECONDARY outcome

Timeframe: 3 to 15 months

Population: 2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. Among these, 30 patients who didn't have sufficient follow-up nor an event were not eligible for analysis of the CEC confirmed major adverse events from 3-month visit to 365 days post 3-month visit.

Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b) * Type 0: No Bleeding * Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment * Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional * Type 3a: Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding * Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents * Type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision * Type 4: CABG-related bleeding within 48 hours * Type 5a: Probable fatal bleeding * Type 5b: Definite fatal bleeding

Outcome measures

Outcome measures
Measure
SYNERGY Stent + 3 Month DAPT
n=1457 Participants
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Number of Participants Who Experienced Major Bleeding
103 Participants

Adverse Events

SYNERGY Stent + 3 Month DAPT

Serious events: 607 serious events
Other events: 100 other events
Deaths: 66 deaths

Serious adverse events

Serious adverse events
Measure
SYNERGY Stent + 3 Month DAPT
n=1487 participants at risk
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Cardiac disorders
Sinus arrest
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Sinus arrhythmia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Sinus bradycardia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Ventricular fibrillation
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Ventricular tachycardia
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Total
17.8%
264/1487 • Number of events 378 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Anaemia
1.3%
20/1487 • Number of events 22 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Anaemia of chronic disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Anaemia of malignant disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Haemorrhagic anaemia
0.54%
8/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Iron deficiency anaemia
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Leukaemoid reaction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Nephrogenic anaemia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Neutropenia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Splenic infarction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Thrombocytopenia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Total
2.6%
38/1487 • Number of events 43 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Acute coronary syndrome
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Acute myocardial infarction
1.4%
21/1487 • Number of events 24 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Acute right ventricular failure
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Angina pectoris
2.2%
33/1487 • Number of events 36 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Angina unstable
1.1%
17/1487 • Number of events 17 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Aortic valve disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Aortic valve stenosis
1.1%
16/1487 • Number of events 17 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Arrhythmia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Atrial fibrillation
4.0%
60/1487 • Number of events 73 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Atrial flutter
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Atrial tachycardia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Atrioventricular block complete
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Bradycardia
0.54%
8/1487 • Number of events 8 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac arrest
0.61%
9/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac failure
1.0%
15/1487 • Number of events 15 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac failure acute
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac failure chronic
0.67%
10/1487 • Number of events 15 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac failure congestive
3.2%
47/1487 • Number of events 61 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiac perforation
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardio-respiratory arrest
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiogenic shock
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiomyopathy
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiopulmonary failure
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Cardiorenal syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Conduction disorder
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Coronary artery disease
1.2%
18/1487 • Number of events 20 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Coronary artery dissection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Coronary artery occlusion
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Coronary artery stenosis
0.67%
10/1487 • Number of events 10 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Extrasystoles
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Intracardiac thrombus
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Ischaemic cardiomyopathy
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Mitral valve incompetence
0.27%
4/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Mitral valve stenosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Myocardial infarction
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Myocardial ischaemia
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Palpitations
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Pericardial effusion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Pulseless electrical activity
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Sick sinus syndrome
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Congenital, familial and genetic disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Ear and labyrinth disorders
Sudden hearing loss
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Ear and labyrinth disorders
Total
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Ear and labyrinth disorders
Vertigo
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Endocrine disorders
Steroid withdrawal syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Endocrine disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Eye disorders
Retinal artery occlusion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Eye disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal adhesions
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal hernia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal pain
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal pain lower
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal pain upper
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal wall haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Abdominal wall haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Ascites
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Constipation
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Diarrhoea
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Duodenal ulcer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Duodenal ulcer haemorrhage
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Dysphagia
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Enteritis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Enterocolitis
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Faecaloma
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gastritis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.3%
20/1487 • Number of events 21 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Haematemesis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Haematochezia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Ileus
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Incarcerated umbilical hernia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Inguinal hernia
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Intestinal ischaemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Intestinal mass
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Intestinal obstruction
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Large intestine polyp
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.54%
8/1487 • Number of events 8 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Mallory-Weiss syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Melaena
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Nausea
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Oesophagitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Pancreatitis
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Pancreatitis acute
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Rectal haemorrhage
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Retroperitoneal haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Small intestinal obstruction
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Total
5.9%
88/1487 • Number of events 104 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.34%
5/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Vomiting
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Adverse drug reaction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Asthenia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Cardiac death
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Catheter site haematoma
0.47%
7/1487 • Number of events 7 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Chest discomfort
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Chest pain
0.87%
13/1487 • Number of events 13 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Coronary artery restenosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Death
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Device lead damage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
General physical health deterioration
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Hypothermia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Impaired healing
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Implant site haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Mucosal inflammation
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Non-cardiac chest pain
2.8%
41/1487 • Number of events 47 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Peripheral swelling
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Pyrexia
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Strangulated hernia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Systemic inflammatory response syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Thrombosis in device
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Total
5.7%
85/1487 • Number of events 96 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Bile duct obstruction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Bile duct stone
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Biliary colic
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Cholangitis
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Cholecystitis
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Cholecystitis acute
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Cholecystitis chronic
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Cholelithiasis
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Hepatic cirrhosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Portal vein thrombosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Hepatobiliary disorders
Total
0.87%
13/1487 • Number of events 17 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Anaphylactic reaction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Drug hypersensitivity
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Kidney transplant rejection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Seasonal allergy
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Immune system disorders
Total
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Abdominal abscess
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Abscess limb
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Appendicitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Bacteraemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Bronchitis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Bronchitis viral
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Catheter site cellulitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Cellulitis
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Clostridium difficile colitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Cytomegalovirus infection
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Cytomegalovirus viraemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Device related infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Diabetic gangrene
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Diverticulitis
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Endocarditis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Endophthalmitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Enterococcal bacteraemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Gastroenteritis
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Herpes zoster
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Herpes zoster disseminated
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Influenza
0.67%
10/1487 • Number of events 10 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Intervertebral discitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Lobar pneumonia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Localised infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Lower respiratory tract infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Osteomyelitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Parainfluenzae virus infection
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Perirectal abscess
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Peritonitis
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Peritonitis bacterial
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Pneumonia
2.3%
34/1487 • Number of events 38 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Postoperative wound infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Proteus infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Pyelonephritis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Respiratory syncytial virus infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Sepsis
1.3%
19/1487 • Number of events 22 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Septic shock
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Subcutaneous abscess
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Total
7.2%
107/1487 • Number of events 147 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Upper respiratory tract infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Urinary tract infection
0.94%
14/1487 • Number of events 17 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Urosepsis
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Viral infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Viral pericarditis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Anaemia postoperative
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Animal scratch
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Ankle fracture
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Bone contusion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Cervical vertebral fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Cystitis radiation
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Fall
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Femoral neck fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Femur fracture
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Head injury
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Hip fracture
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Humerus fracture
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Incisional hernia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Laceration
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Limb injury
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Muscle strain
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Near drowning
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural discomfort
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural haematoma
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural swelling
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Procedural complication
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Procedural haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Procedural hypotension
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Procedural pain
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Radius fracture
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Rib fracture
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Road traffic accident
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Spinal compression fracture
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Spinal cord injury cervical
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Subdural haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Tendon rupture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Tibia fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Total
4.8%
72/1487 • Number of events 84 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Traumatic fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Upper limb fracture
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Vascular procedure complication
0.67%
10/1487 • Number of events 11 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.81%
12/1487 • Number of events 12 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Venous injury
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Wound dehiscence
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Blood pressure decreased
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Computerised tomogram abdomen abnormal
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Hepatic enzyme increased
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
International normalised ratio increased
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Total
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Troponin increased
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Dehydration
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Diabetes mellitus
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Fluid overload
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Gout
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Hyperglycaemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Hyperkalaemia
0.27%
4/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Hypokalaemia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Malnutrition
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Metabolic acidosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Metabolism and nutrition disorders
Total
1.2%
18/1487 • Number of events 20 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Arthralgia
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Arthritis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Back pain
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Bone lesion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Costochondritis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Foot deformity
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Hungry bone syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Myalgia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.54%
8/1487 • Number of events 8 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Pain in extremity
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Scoliosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Tendon disorder
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Total
2.2%
33/1487 • Number of events 38 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage III
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Total
3.4%
50/1487 • Number of events 54 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Aphasia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Ataxia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Brain oedema
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Carotid artery stenosis
0.54%
8/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebellar haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebral haemorrhage
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebral infarction
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebrovascular accident
0.87%
13/1487 • Number of events 14 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebrovascular disorder
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Coma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Convulsion
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Dementia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Dementia Alzheimer's type
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Dementia with Lewy bodies
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Dizziness
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Dysarthria
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Embolic stroke
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Encephalopathy
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Haemorrhage intracranial
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Headache
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Hepatic encephalopathy
0.07%
1/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Intracranial aneurysm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Ischaemic stroke
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Metabolic encephalopathy
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Migraine
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Monoparesis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Myasthenic syndrome
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Orthostatic intolerance
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Parkinson's disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Presyncope
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Sciatica
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Subarachnoid haemorrhage
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Syncope
0.67%
10/1487 • Number of events 11 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Tension headache
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Total
5.4%
80/1487 • Number of events 95 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Transient ischaemic attack
0.47%
7/1487 • Number of events 7 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Psychiatric disorders
Mental status changes
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Psychiatric disorders
Neurosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Psychiatric disorders
Total
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Bladder neck obstruction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Calculus ureteric
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Diabetic end stage renal disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Haematuria
0.54%
8/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Nephrolithiasis
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Obstructive uropathy
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal artery stenosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal failure
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal failure acute
2.4%
35/1487 • Number of events 39 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal failure chronic
0.74%
11/1487 • Number of events 11 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Renal impairment
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Total
4.7%
70/1487 • Number of events 84 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Urethral stenosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Urinary retention
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Pelvic haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Priapism
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Prostatomegaly
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Total
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Aspiration
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Asthma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
1.1%
16/1487 • Number of events 18 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Diaphragmatic spasm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.67%
10/1487 • Number of events 12 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.47%
7/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.34%
5/1487 • Number of events 7 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.40%
6/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.61%
9/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Total
4.9%
73/1487 • Number of events 86 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Angioedema
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Blister
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Skin lesion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Total
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Aortic aneurysm
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Aortic dissection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Aortic stenosis
0.34%
5/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Arterial occlusive disease
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Arteriosclerosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Deep vein thrombosis
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Femoral artery aneurysm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Haematoma
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Hypertension
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Hypertensive crisis
0.40%
6/1487 • Number of events 8 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Hypertensive emergency
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Hypotension
0.67%
10/1487 • Number of events 11 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Intermittent claudication
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Orthostatic hypotension
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Peripheral arterial occlusive disease
0.34%
5/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Peripheral artery stenosis
0.20%
3/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Peripheral ischaemia
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Peripheral vascular disorder
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Shock
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Thrombophlebitis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Total
3.6%
54/1487 • Number of events 68 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Venous thrombosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death

Other adverse events

Other adverse events
Measure
SYNERGY Stent + 3 Month DAPT
n=1487 participants at risk
Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin) 3 months of dual antiplatelet therapy (DAPT): 3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin SYNERGY Stent System: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Blood and lymphatic system disorders
Anaemia
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Blood and lymphatic system disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Acute myocardial infarction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Myocardial infarction
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Cardiac disorders
Total
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Eye disorders
Eye haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Eye disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gastritis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Gingival bleeding
0.27%
4/1487 • Number of events 5 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Haematochezia
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Haemorrhoids
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Melaena
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Rectal haemorrhage
0.61%
9/1487 • Number of events 9 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Gastrointestinal disorders
Total
1.5%
22/1487 • Number of events 25 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Catheter site haematoma
0.47%
7/1487 • Number of events 7 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Catheter site haemorrhage
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Implant site haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
General disorders
Total
0.74%
11/1487 • Number of events 11 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Infections and infestations
Urinary tract infection
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Anaemia postoperative
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Contusion
0.34%
5/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Incision site haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Laceration
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural haematuria
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Procedural haemorrhage
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Skin abrasion
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Skin injury
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Subcutaneous haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Total
1.5%
23/1487 • Number of events 26 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Traumatic haematoma
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Traumatic haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Vascular procedure complication
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Wound
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Injury, poisoning and procedural complications
Wound haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Occult blood
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Investigations
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Joint swelling
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Musculoskeletal and connective tissue disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Cerebral infarction
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Nervous system disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Haematuria
1.0%
15/1487 • Number of events 18 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Renal and urinary disorders
Total
1.0%
15/1487 • Number of events 18 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Total
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Reproductive system and breast disorders
Vaginal haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Epistaxis
1.7%
26/1487 • Number of events 28 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Respiratory, thoracic and mediastinal disorders
Total
1.8%
27/1487 • Number of events 30 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Ecchymosis
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.20%
3/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Skin and subcutaneous tissue disorders
Total
0.27%
4/1487 • Number of events 4 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Bleeding varicose vein
0.13%
2/1487 • Number of events 2 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Haematoma
0.13%
2/1487 • Number of events 3 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Haemorrhage
0.07%
1/1487 • Number of events 1 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death
Vascular disorders
Total
0.34%
5/1487 • Number of events 6 • Study start to end of study (15 month)
2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints. 66 patients passed away between 3 month and end of study. Patients who passed away before 3 month are not considered eligible for the primary endpoint analysis. Death for unknown reason are reported as Death or cardiac Death

Additional Information

Peter Maurer, Director Clinical Trials

Boston Scientific Corp.

Phone: +1 (508) 683

Results disclosure agreements

  • Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor
  • Publication restrictions are in place

Restriction type: OTHER