Trial Outcomes & Findings for Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions (NCT NCT02229864)
NCT ID: NCT02229864
Last Updated: 2021-03-12
Results Overview
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
COMPLETED
NA
12 participants
0 to 30 days
2021-03-12
Participant Flow
The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.
In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Participant milestones
| Measure |
Coronary Artery Stenting: Absorb BVS
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Coronary Artery Stenting: Absorb BVS
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
Baseline characteristics by cohort
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm
|
|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Hypertension Requiring Medication
|
12 Participants
n=5 Participants
|
|
Dyslipidemia Requiring Medication
|
12 Participants
n=5 Participants
|
|
Prior Coronary Intervention
|
1 Participants
n=5 Participants
|
|
Stable Angina
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Maximum Concentration (Cmax)
|
2.397 nanograms per milliliter
Interval 1.085 to 4.46
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Time of Maximum (Tmax)
|
0.55 Hours
Interval 0.17 to 2.37
|
PRIMARY outcome
Timeframe: 0 to 24 hoursPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
AUC24h
|
22.67 ng*h/mL
Interval 12.09 to 44.22
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
AUC Last
|
55.90 ng*h/mL
Interval 25.37 to 104.6
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ \* 100
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
AUC 0-infinity
|
72.02 ng*h/mL
Interval 33.15 to 120.8
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.01092 1/hour
Interval 0.006027 to 0.01511
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Terminal Elimination Half-life (t1/2term)
|
63.5 Hours
Interval 45.9 to 115.0
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ .
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Drug Clearance (CL)
|
3.451 Liter/hour
Interval 2.421 to 5.46
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
|
2 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
All death includes cardiac death, vascular death, and non-cardiac death.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With All Death
|
2 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI)
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With All Target Lesion Revascularization (TLR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With All Target Vessel Revascularization (TVR)
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With All Revascularization
|
3 Participants
|
SECONDARY outcome
Timeframe: ≤ 1 dayPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)
|
0 Participants
|
SECONDARY outcome
Timeframe: >1 to 30 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)
|
0 Participants
|
SECONDARY outcome
Timeframe: 31 to 393 daysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Outcome measures
| Measure |
Coronary Artery Stenting: Absorb BVS
n=11 Participants
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).
Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
|
|---|---|
|
Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
|
0 Participants
|
Adverse Events
Coronary Artery Stenting: Absorb BVS
Serious adverse events
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 participants at risk
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm
|
|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS AGGRAVATED
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION AGGRAVATED
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
NON STEMI
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
STABLE ANGINA PECTORIS
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
UNSTABLE ANGINA
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL BLEEDING
|
8.3%
1/12 • 5 years
|
|
General disorders
CHEST PAIN
|
8.3%
1/12 • 5 years
|
|
General disorders
CHEST PAIN (NON-CARDIAC)
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
BRONCHITIS
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
CELLULITIS
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
CELLULITIS OF LEG
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
SEPSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
25.0%
3/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAINFULL ARM
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL STENOSIS OF LUMBAR REGION
|
8.3%
1/12 • 5 years
|
|
Renal and urinary disorders
ACUTE ON CHRONIC RENAL FAILURE
|
8.3%
1/12 • 5 years
|
|
Renal and urinary disorders
ACUTE RENAL FAILURE
|
8.3%
1/12 • 5 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERTROPHY
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
8.3%
1/12 • 5 years
|
|
Vascular disorders
POPLITEAL VEIN THROMBOSIS
|
8.3%
1/12 • 5 years
|
Other adverse events
| Measure |
Coronary Artery Stenting: Absorb BVS
n=12 participants at risk
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm
|
|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
25.0%
3/12 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS AGGRAVATED
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION AGGRAVATED
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
BRADYCARDIA
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
16.7%
2/12 • 5 years
|
|
Cardiac disorders
CONGESTIVE HEART FAILURE
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
25.0%
3/12 • 5 years
|
|
Cardiac disorders
CORONARY NO-REFLOW PHENOMENON
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
NON STEMI
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
STABLE ANGINA PECTORIS
|
8.3%
1/12 • 5 years
|
|
Cardiac disorders
UNSTABLE ANGINA
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
HEARTBURN
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.3%
1/12 • 5 years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL BLEEDING
|
8.3%
1/12 • 5 years
|
|
General disorders
CHEST PAIN
|
8.3%
1/12 • 5 years
|
|
General disorders
CHEST PAIN (NON-CARDIAC)
|
33.3%
4/12 • 5 years
|
|
General disorders
INFUSION SITE HEMATOMA
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
BRONCHITIS
|
16.7%
2/12 • 5 years
|
|
Infections and infestations
CELLULITIS
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
CELLULITIS OF LEG
|
8.3%
1/12 • 5 years
|
|
Infections and infestations
SEPSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
BRUISE
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL MYOCARDIAL INFARCTION
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE HYPOTENSION
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
TICK BITE
|
8.3%
1/12 • 5 years
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
8.3%
1/12 • 5 years
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
16.7%
2/12 • 5 years
|
|
Investigations
CREATINE KINASE MB INCREASED
|
25.0%
3/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN AGGRAVATED
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
25.0%
3/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MONOARTHRITIS
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAINFUL L ARM
|
8.3%
1/12 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL STENOSIS OF LUMBAR REGION
|
8.3%
1/12 • 5 years
|
|
Nervous system disorders
DIZZINESS
|
8.3%
1/12 • 5 years
|
|
Nervous system disorders
SCIATICA
|
8.3%
1/12 • 5 years
|
|
Renal and urinary disorders
ACUTE ON CHRONIC RENAL FAILURE
|
8.3%
1/12 • 5 years
|
|
Renal and urinary disorders
ACUTE RENAL FAILURE
|
8.3%
1/12 • 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
8.3%
1/12 • 5 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERTROPHY
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE SLEEP APNEA SYNDROME
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
8.3%
1/12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
8.3%
1/12 • 5 years
|
|
Vascular disorders
HYPOTENSION
|
8.3%
1/12 • 5 years
|
|
Vascular disorders
POPLITEAL VEIN THROMBOSIS
|
8.3%
1/12 • 5 years
|
|
Vascular disorders
SLOW REFLOW PHENOMENON
|
8.3%
1/12 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators shall not present or publish, nor submit for publication, any work resulting from the Services without Sponsor's prior written approval. Except as specifically set forth herein, neither party shall use the other party's name or trademark, or the name nor trademark of such other party's affiliate, in any publicity, advertising or announcement, or disclose the existence or terms of this Agreement, without the consenting party's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER