Trial Outcomes & Findings for XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients. (NCT NCT03218787)
NCT ID: NCT03218787
Last Updated: 2021-11-05
Results Overview
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block, development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI: CK-MB \> URL or Troponin \> URL with baseline value \< UR The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome \& the baseline demographic, clinical and procedural covariates as the predictors
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2047 participants
Primary outcome timeframe
From 3 to 12 months
Results posted on
2021-11-05
Participant Flow
A total of 2047 subjects were registered in XIENCE 90 from 101 sites in the US between 19 July, 2017 and 09 August, 2019. The last patient visit was on 04 September, 2020.
Participant milestones
| Measure |
XIENCE
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Overall Study
STARTED
|
2047
|
|
Overall Study
COMPLETED
|
1841
|
|
Overall Study
NOT COMPLETED
|
206
|
Reasons for withdrawal
| Measure |
XIENCE
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Withdrawal by Subject
|
72
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Death
|
111
|
Baseline Characteristics
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
Baseline characteristics by cohort
| Measure |
XIENCE
n=2047 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Age, Continuous
|
75.10 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
726 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1321 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1804 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Did not wish to disclose
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not available
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2047 Participants
n=5 Participants
|
|
Chronic anticoagulant
|
836 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block, development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI * Spontaneous MI: CK-MB \> URL or Troponin \> URL with baseline value \< UR The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome \& the baseline demographic, clinical and procedural covariates as the predictors
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Adjusted Overall Rate
|
5.4 Percentage of participants
|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Q1
|
6.7 Percentage of participants
|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Q2
|
4.0 Percentage of participants
|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Q3
|
3.6 Percentage of participants
|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Q4
|
5.8 Percentage of participants
|
|
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Q5
|
6.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
* Type 2: Any overt, actionable sign of hemorrhage * Type 3a: Overt bleeding plus Hb drop of 3 to \< 5g/dL;Any transfusion with overt bleeding * Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents * Type 3c: ICH; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision * Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood or packed RBC within 48h;Chest tube output ≥ 2L within 24h * Type 5: Fatal bleeding The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome \& the baseline demographic, clinical and procedural covariates as the predictors.
Outcome measures
| Measure |
XIENCE
n=1629 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Adjusted Overall Rate
|
5.1 Percentage of participants
|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Q1
|
3.9 Percentage of participants
|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Q2
|
2.7 Percentage of participants
|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Q3
|
5.4 Percentage of participants
|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Q4
|
6.0 Percentage of participants
|
|
Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Q5
|
7.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Outcome measures
| Measure |
XIENCE
n=1635 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ARC Definite/Probable)
|
4 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
|
54 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
|
48 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: * Clinical symptoms of ischemia; * ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; * Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: * Periprocedural MI: * Within 48h after PCI: CK-MB \>3 x URL or Troponin \> 3 x URL with baseline value \< URL * Within 72h after CABG: CK-MB \>5 x URL or Troponin \> 5 x URL with baseline value \< URL * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
|
67 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. * Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. * Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. * Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. * Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Outcome measures
| Measure |
XIENCE
n=1624 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
|
21 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. Clinically Indicated \[CI\] Revascularization: A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test * A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
16 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: * A positive history of recurrent angina pectoris, presumably related to the target vessel; * Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; * Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); * A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
26 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
|
66 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Outcome measures
| Measure |
XIENCE
n=1672 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
|
70 Participants
|
SECONDARY outcome
Timeframe: From 3 to 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows: * Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to \< 5 g/dL; Any transfusion with overt bleeding * Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents * Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision * Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period * Type 5: Fatal bleeding * Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious * Type 5b: Definite fatal bleeding;overt bleeding or autopsy or imaging confirmation
Outcome measures
| Measure |
XIENCE
n=1629 Participants
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
|
41 Participants
|
Adverse Events
XIENCE
Serious events: 898 serious events
Other events: 129 other events
Deaths: 115 deaths
Serious adverse events
| Measure |
XIENCE
n=2047 participants at risk
Subjects will receive XIENCE family stent systems and 3-month DAPT
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.98%
20/2047 • Number of events 20 • 1 Year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
60/2047 • Number of events 62 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.68%
14/2047 • Number of events 15 • 1 Year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.34%
7/2047 • Number of events 7 • 1 Year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Acute left ventricular failure
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Cardiac disorders
Angina pectoris
|
7.1%
146/2047 • Number of events 180 • 1 Year
|
|
Cardiac disorders
Angina unstable
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Cardiac disorders
Aortic valve incompetence
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Cardiac disorders
Arrhythmia
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Atrial fibrillation
|
4.9%
101/2047 • Number of events 116 • 1 Year
|
|
Cardiac disorders
Atrial flutter
|
0.73%
15/2047 • Number of events 16 • 1 Year
|
|
Cardiac disorders
Atrial tachycardia
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Atrioventricular block
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Bradyarrhythmia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.98%
20/2047 • Number of events 21 • 1 Year
|
|
Cardiac disorders
Bundle branch block left
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
16/2047 • Number of events 16 • 1 Year
|
|
Cardiac disorders
Cardiac disorder
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Cardiac failure
|
0.68%
14/2047 • Number of events 15 • 1 Year
|
|
Cardiac disorders
Cardiac failure acute
|
0.54%
11/2047 • Number of events 12 • 1 Year
|
|
Cardiac disorders
Cardiac failure chronic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac failure congestive
|
4.3%
87/2047 • Number of events 109 • 1 Year
|
|
Cardiac disorders
Cardiac perforation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Cardiac disorders
Cardiogenic shock
|
0.39%
8/2047 • Number of events 9 • 1 Year
|
|
Cardiac disorders
Cardiomyopathy
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Coronary artery disease
|
0.73%
15/2047 • Number of events 15 • 1 Year
|
|
Cardiac disorders
Coronary artery dissection
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Mitral valve disease
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Mitral valve stenosis
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
56/2047 • Number of events 65 • 1 Year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Nodal rhythm
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Palpitations
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Cardiac disorders
Pericardial effusion
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Pericarditis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Right ventricular failure
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Sinus arrest
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Sinus arrhythmia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Sinus bradycardia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Cardiac disorders
Tachycardia
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.59%
12/2047 • Number of events 12 • 1 Year
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Endocrine disorders
Hyperparathyroidism
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Age-related macular degeneration
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Cataract
|
0.15%
3/2047 • Number of events 4 • 1 Year
|
|
Eye disorders
Conjunctival haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Eye haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Glaucoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Macular fibrosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Retinal haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Retinoschisis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Vision blurred
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Eye disorders
Visual impairment
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Ascites
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Colitis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Colonic polyp
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Dental caries
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Diverticulum
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Dysphagia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Enterocolitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
43/2047 • Number of events 46 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Haematemesis
|
0.34%
7/2047 • Number of events 7 • 1 Year
|
|
Gastrointestinal disorders
Haematochezia
|
0.44%
9/2047 • Number of events 9 • 1 Year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Ileus
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Gastrointestinal disorders
Melaena
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Oesophageal hypomotility
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.34%
7/2047 • Number of events 7 • 1 Year
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
8/2047 • Number of events 8 • 1 Year
|
|
Gastrointestinal disorders
Swollen tongue
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Toothache
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.29%
6/2047 • Number of events 7 • 1 Year
|
|
Gastrointestinal disorders
Volvulus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.15%
3/2047 • Number of events 4 • 1 Year
|
|
General disorders
Accidental death
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Asthenia
|
0.44%
9/2047 • Number of events 10 • 1 Year
|
|
General disorders
Catheter site haematoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Catheter site haemorrhage
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
General disorders
Chest discomfort
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
General disorders
Chest pain
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
General disorders
Death
|
0.44%
9/2047 • Number of events 9 • 1 Year
|
|
General disorders
Device capturing issue
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Device malfunction
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
General disorders
Feeling hot
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Gait disturbance
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
General physical health deterioration
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Hernia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Injection site extravasation
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Injection site haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Malaise
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Multi-organ failure
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
General disorders
Non-cardiac chest pain
|
1.8%
37/2047 • Number of events 40 • 1 Year
|
|
General disorders
Oedema peripheral
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
General disorders
Pyrexia
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
General disorders
Systemic inflammatory response syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
General disorders
Thrombosis in device
|
0.15%
3/2047 • Number of events 6 • 1 Year
|
|
General disorders
Ulcer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatic failure
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Hepatobiliary disorders
Jaundice
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Immune system disorders
Anaphylactic shock
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Immune system disorders
Antiphospholipid syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Immune system disorders
Contrast media allergy
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Immune system disorders
Drug hypersensitivity
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Immune system disorders
Food allergy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Immune system disorders
Pancreas transplant rejection
|
0.05%
1/2047 • Number of events 2 • 1 Year
|
|
Immune system disorders
Sarcoidosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Abdominal abscess
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Abscess neck
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Appendicitis perforated
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Arteritis infective
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Arthritis bacterial
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Infections and infestations
Bacteraemia
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Infections and infestations
Bacterial infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Bronchitis
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Infections and infestations
Bronchitis bacterial
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Catheter site infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Cellulitis
|
1.1%
22/2047 • Number of events 22 • 1 Year
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Cystitis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Infections and infestations
Device related infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Endocarditis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Escherichia bacteraemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Eye infection staphylococcal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Gangrene
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Gastroenteritis viral
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Hepatitis B
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Implant site infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Incision site infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Infected skin ulcer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Influenza
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Infections and infestations
Lobar pneumonia
|
0.24%
5/2047 • Number of events 6 • 1 Year
|
|
Infections and infestations
Localised infection
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Infections and infestations
Nasopharyngitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Osteomyelitis
|
0.68%
14/2047 • Number of events 14 • 1 Year
|
|
Infections and infestations
Parotitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Perineal abscess
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pneumonia
|
2.3%
47/2047 • Number of events 52 • 1 Year
|
|
Infections and infestations
Pneumonia primary atypical
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Post procedural infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pulmonary sepsis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pyelonephritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Infections and infestations
Respiratory tract infection viral
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Rhinovirus infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.54%
11/2047 • Number of events 12 • 1 Year
|
|
Infections and infestations
Septic embolus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Septic shock
|
0.34%
7/2047 • Number of events 7 • 1 Year
|
|
Infections and infestations
Staphylococcal abscess
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Staphylococcal sepsis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Infections and infestations
Tooth abscess
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
1.1%
22/2047 • Number of events 24 • 1 Year
|
|
Infections and infestations
Urinary tract infection fungal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Urosepsis
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Infections and infestations
Wound abscess
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Infections and infestations
Wound infection
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Complications of transplanted pancreas
|
0.05%
1/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.39%
8/2047 • Number of events 8 • 1 Year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Injury
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.49%
10/2047 • Number of events 10 • 1 Year
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Investigations
Blood creatinine increased
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Blood pressure increased
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Blood urine present
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Investigations
Cardiac monitoring
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Ejection fraction decreased
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Hepatic enzyme increased
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Occult blood positive
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Investigations
Troponin increased
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Investigations
White blood cell count increased
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
10/2047 • Number of events 10 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.49%
10/2047 • Number of events 10 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.44%
9/2047 • Number of events 9 • 1 Year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Obesity
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
10/2047 • Number of events 10 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.05%
1/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia plasmacytic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant splenic neoplasm
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Amnesia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Carotid artery stenosis
|
0.44%
9/2047 • Number of events 9 • 1 Year
|
|
Nervous system disorders
Central nervous system lesion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Cerebral infarction
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
40/2047 • Number of events 42 • 1 Year
|
|
Nervous system disorders
Cervical cord compression
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Convulsion
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Nervous system disorders
Dementia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Depressed level of consciousness
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Diplegia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Dizziness
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Nervous system disorders
Dysarthria
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Encephalopathy
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Nervous system disorders
Essential tremor
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Frontotemporal dementia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Hemiparesis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Hypoaesthesia
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Nervous system disorders
Hypokinesia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Intracranial aneurysm
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Lethargy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Nervous system disorders
Mononeuropathy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Paraesthesia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Parkinsonism
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Presyncope
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Nervous system disorders
Radiculopathy
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Sciatica
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Somnolence
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Speech disorder
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Syncope
|
1.3%
27/2047 • Number of events 32 • 1 Year
|
|
Nervous system disorders
Toxic encephalopathy
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.59%
12/2047 • Number of events 12 • 1 Year
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Vascular dementia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Anxiety
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Confusional state
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Psychiatric disorders
Depression
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Insomnia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Psychiatric disorders
Mental status changes
|
0.24%
5/2047 • Number of events 7 • 1 Year
|
|
Renal and urinary disorders
Bladder mass
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Calculus ureteric
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Calculus urethral
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Renal and urinary disorders
Haematuria
|
0.44%
9/2047 • Number of events 10 • 1 Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Renal and urinary disorders
Renal cyst
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Renal disorder
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Renal and urinary disorders
Renal failure acute
|
2.1%
44/2047 • Number of events 48 • 1 Year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.49%
10/2047 • Number of events 10 • 1 Year
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Renal impairment
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Renal and urinary disorders
Renal mass
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Urethral stenosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Urinary incontinence
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
34/2047 • Number of events 38 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.68%
14/2047 • Number of events 21 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
33/2047 • Number of events 36 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.39%
8/2047 • Number of events 8 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.73%
15/2047 • Number of events 16 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.44%
9/2047 • Number of events 9 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.20%
4/2047 • Number of events 4 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.93%
19/2047 • Number of events 21 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
8/2047 • Number of events 8 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.83%
17/2047 • Number of events 17 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Accelerated hypertension
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Aortic stenosis
|
0.88%
18/2047 • Number of events 18 • 1 Year
|
|
Vascular disorders
Arteriovenous fistula
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Deep vein thrombosis
|
0.24%
5/2047 • Number of events 5 • 1 Year
|
|
Vascular disorders
Extremity necrosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Femoral arterial stenosis
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Vascular disorders
Haematoma
|
0.64%
13/2047 • Number of events 13 • 1 Year
|
|
Vascular disorders
Haemorrhage
|
0.29%
6/2047 • Number of events 6 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.59%
12/2047 • Number of events 12 • 1 Year
|
|
Vascular disorders
Hypertensive crisis
|
0.39%
8/2047 • Number of events 8 • 1 Year
|
|
Vascular disorders
Hypertensive emergency
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Vascular disorders
Hypotension
|
1.3%
26/2047 • Number of events 27 • 1 Year
|
|
Vascular disorders
Hypovolaemic shock
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Iliac artery stenosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Intermittent claudication
|
0.29%
6/2047 • Number of events 7 • 1 Year
|
|
Vascular disorders
Jugular vein thrombosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Lymphorrhoea
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Malignant hypertension
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Orthostatic hypotension
|
0.15%
3/2047 • Number of events 3 • 1 Year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.29%
6/2047 • Number of events 7 • 1 Year
|
|
Vascular disorders
Peripheral ischaemia
|
0.29%
6/2047 • Number of events 7 • 1 Year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.10%
2/2047 • Number of events 3 • 1 Year
|
|
Vascular disorders
Reperfusion injury
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Secondary hypertension
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Shock
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Steal syndrome
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Subclavian artery stenosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Vascular disorders
Thrombophlebitis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Thrombosis
|
0.10%
2/2047 • Number of events 2 • 1 Year
|
|
Vascular disorders
Venous occlusion
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
|
Vascular disorders
Venous stenosis
|
0.05%
1/2047 • Number of events 1 • 1 Year
|
Other adverse events
| Measure |
XIENCE
n=2047 participants at risk
Subjects will receive XIENCE family stent systems and 3-month DAPT
XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month
DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
6.3%
129/2047 • Number of events 139 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER