Trial Outcomes & Findings for SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy (NCT NCT03606642)
NCT ID: NCT03606642
Last Updated: 2024-12-27
Results Overview
Rate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
1 to 13 months
Results posted on
2024-12-27
Participant Flow
An Interim Analysis was completed on December 10, 2021 (Attachment 3) after the 50th enrolled subject completed the 60 day follow up visit. The DSMC (16MAR2022) reviewed the Interim Analysis and recommended to end the study at interim analysis due to no glaring outcomes from the study. They did not see a need to continue, simply due to other similar studies have been completed for similar devices and the point that DAPT can safely be discontinued for High Risk Bleeding patients has been shown.
Participant milestones
| Measure |
PCI With 30 Day DAPT Therapy
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID (twice a day).
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy
Baseline characteristics by cohort
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Age, Customized
Greater than or equal to 75 years of age
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 to 13 monthsRate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With Cardiac Death
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 to 13 monthsRate of myocardial infarction (SCAI definition) from 1 to 13 months post-index procedure in the overall enrolled "intent-to-treat" patient population
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Rate of Myocardial Infarction
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsRate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) involving SYNERGY Stent® from 1 to 13 months post-index procedure
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With Definite/Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsRate of major bleeding (GUSTO severe/life threatening + moderate)
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With Major Bleeding
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsAngina Assessment
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With Ischemia-driven (ID) Target Vessel Revascularization,
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsAngina Assessment
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With Target Vessel Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsAngina Assessment
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With All-Cause Death
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 to 13 monthsAngina Assessment
Outcome measures
| Measure |
PCI With 30 Day DAPT Therapy
n=50 Participants
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Number of Participants With All-Cause MI (Myocardial Infarction)
|
1 Participants
|
Adverse Events
PCI With 30 Day DAPT Therapy
Serious events: 31 serious events
Other events: 44 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
PCI With 30 Day DAPT Therapy
n=50 participants at risk
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Blood and lymphatic system disorders
Frontal cerebral bleed/hemorrhagic stroke
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
Intracranial Hemorrhage
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
Progression of Lymphoma
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
Hematoma - Pelvis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Chest Pain
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
coranary artery disease- OM1
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Cardiac Death
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Tachy Brady Syndrome
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Acute Congestive Heart Failure
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Acute decompensated heart failure
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Atherosclerosis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
GI Bleed
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Acute Abdominal Pain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
intractable nausea and vomiting
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
Intrahepatic duct dilatation
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
multisystem organ dysfunction
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
Atypical Chest Pain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Sepsis
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
pneumonia
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
SARS-CoV-2
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Abscess
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Gangrene
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Urinary Tract Infection w/Hematuria
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
hyperglycemia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Leg fracture
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinosarcoma of bladder
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
dizzines
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Tremors
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Renal and urinary disorders
Acute Pyelonephritis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Reproductive system and breast disorders
Endometrial Thickening
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Reproductive system and breast disorders
Abnormal Vaginal Bleeding
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Surgical and medical procedures
Anemia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Systemic Inflammatory Syndrome
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Ischemic Foot
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Surgical and medical procedures
Occlusion of graft right leg
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Peripheral Vascular Disease
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
Other adverse events
| Measure |
PCI With 30 Day DAPT Therapy
n=50 participants at risk
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Dual Antiplatelet (DAPT) Therapy: DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
P2Y12 Inhibitor Loading Dose (investigator preference):
Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
P2Y12 Inhibitor Maintenance Dose (investigator preference):
Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.
The Synergy® stent: IVUS guided stent
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.0%
7/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
bruising
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
prolonged bleeding
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Blood in stool
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
Hematuria
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Eye disorders
subhyaloid hemorrhage
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Blood and lymphatic system disorders
neutropenic fever
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
pancytopenia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
atrial tachycardia
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Bradycardia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Chest pain
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Elevated Cardiac enzymes
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Hypertension
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Hypotension
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Junctional Rhythm
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Cardiac disorders
Angina
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Eye disorders
subconjunctival hemorrhage
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
vomiting
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
abdominal pain
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
gastroenteritis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
Atypical Chest Pain
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
root canal
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
General disorders
Ground level fall
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Ear and labyrinth disorders
Ear Fullness
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Gastrointestinal disorders
pain/leak from gastrointestinal tube site
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Hepatobiliary disorders
Gallstones
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Immune system disorders
Allergic Reaction
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
SARS CoV2
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
10.0%
5/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
venous statis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Strain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Acute exacerbation of chronic lower back pain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Xyphoidalgia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Facial Trauma
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Dizziness
|
16.0%
8/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Seizure
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Altered Mental Status
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Nervous system disorders
Closed-head injury
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Renal and urinary disorders
ureteral sone
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Reproductive system and breast disorders
endometrial hyperplasia
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Reproductive system and breast disorders
endometrial polyps
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Reproductive system and breast disorders
endocervical polyp
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
12.0%
6/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Respiratory, thoracic and mediastinal disorders
metabolic acidosis
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Skin and subcutaneous tissue disorders
rash
|
6.0%
3/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Pedal Edema
|
4.0%
2/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Peripheral artery disease
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
pseudoaneurysm
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
|
|
Vascular disorders
Fistula
|
2.0%
1/50 • up to 1 year 3 months
A total of 44 non- serious adverse effects have been reported across all sites. Incidence has been as expected for non-cardiac chest discomfort. Others have been varied throughout the study. A total of 93 Moderates adverse effects have been reported across all sites which include some hospitalizations.
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Additional Information
Joanne Saczynski, MSN, RN, ACRP-CP
HonorHealth Research Institute
Phone: 480-323-1046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place