Trial Outcomes & Findings for A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT) (NCT NCT01334918)
NCT ID: NCT01334918
Last Updated: 2024-12-04
Results Overview
The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17.
COMPLETED
PHASE2
124 participants
Day 1 and Day 2
2024-12-04
Participant Flow
Participant milestones
| Measure |
Sequence 1: SPECT - MDCT
Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure. Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
Sequence 2: MDCT - SPECT
Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure. Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
61
|
|
Overall Study
Randomized + 1 Stress Scan
|
57
|
61
|
|
Overall Study
COMPLETED
|
55
|
60
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1: SPECT - MDCT
Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure. Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
Sequence 2: MDCT - SPECT
Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure. Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
|---|---|---|
|
Overall Study
Did not receive study drug
|
6
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
Baseline characteristics by cohort
| Measure |
Sequence 1: SPECT - MDCT
n=57 Participants
Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure. Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
Sequence 2: MDCT - SPECT
n=61 Participants
Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure. Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
52 participants
n=5 Participants
|
54 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
37 participants
n=5 Participants
|
41 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.
The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=85 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=25 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=110 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reversible Defects
SPECT: 0-1 Reversible defects
|
84 participants
|
16 participants
|
100 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects
SPECT: ≥ 2 Reversible defects
|
1 participants
|
9 participants
|
10 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects
SPECT: All Reversible defects
|
85 participants
|
25 participants
|
110 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set.
Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=110 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=110 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=110 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
n=110 Participants
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
n=110 Participants
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
n=110 Participants
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Overall Image Quality of Scans by Modality and Reviewer
Rest: Good
|
16 participants
|
53 participants
|
23 participants
|
56 participants
|
37 participants
|
43 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Rest: Excellent
|
89 participants
|
25 participants
|
83 participants
|
30 participants
|
40 participants
|
56 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Rest: Fair
|
4 participants
|
31 participants
|
4 participants
|
23 participants
|
33 participants
|
11 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Rest: Poor
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Stress: Excellent
|
89 participants
|
35 participants
|
78 participants
|
5 participants
|
15 participants
|
37 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Stress: Good
|
16 participants
|
51 participants
|
27 participants
|
48 participants
|
24 participants
|
36 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Stress: Fair
|
4 participants
|
24 participants
|
5 participants
|
56 participants
|
62 participants
|
34 participants
|
|
Overall Image Quality of Scans by Modality and Reviewer
Stress: Poor
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
9 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set where scans were available.
The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=90 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=15 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=105 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
SPECT: 0 - 1 Reversible defects
|
90 participants
|
11 participants
|
101 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
SPECT: ≥ 2 Reversible defects
|
0 participants
|
4 participants
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
SPECT: All Reversible defects
|
90 participants
|
15 participants
|
105 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set where scans were available.
The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=93 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=5 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=98 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
SPECT: 0 - 1 Reversible defects
|
92 participants
|
5 participants
|
97 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
SPECT: ≥ 2 Reversible defects
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
SPECT: All Reversible defects
|
93 participants
|
5 participants
|
98 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set where scans were available.
The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=92 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=13 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=105 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
SPECT: 0 - 1 Reversible defects
|
90 participants
|
9 participants
|
99 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
SPECT: ≥ 2 Reversible defects
|
2 participants
|
4 participants
|
6 participants
|
—
|
—
|
—
|
|
Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
SPECT: All Reversible defects
|
92 participants
|
13 participants
|
105 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: The number of participants analyzed represents the full analysis set.
Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: -0: normal perfusion -1: slightly reduced contrast/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=95 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
n=15 Participants
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
n=110 Participants
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Fixed Defects
SPECT: 0 Fixed Defects
|
92 participants
|
5 participants
|
97 participants
|
—
|
—
|
—
|
|
Number of Participants With Fixed Defects
SPECT: ≥ 1 Fixed Defects
|
3 participants
|
10 participants
|
13 participants
|
—
|
—
|
—
|
|
Number of Participants With Fixed Defects
SPECT: All Fixed Defects
|
95 participants
|
15 participants
|
110 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: Full analysis set participants with two or more reversible defects.
Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.
Outcome measures
| Measure |
CTP: 0 - 1 Reversible Defects
n=10 Participants
Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: ≥ 2 Reversible Defects
Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
|
CTP: All Reversible Defects
All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
|
MDCT: Reviewer 1
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
|
MDCT: Reviewer 2
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
|
MDCT: Reviewer 3
Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SPECT
MDCT
Serious adverse events
| Measure |
SPECT
n=117 participants at risk
Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
|
MDCT
n=116 participants at risk
Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.85%
1/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
0.00%
0/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
Other adverse events
| Measure |
SPECT
n=117 participants at risk
Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
|
MDCT
n=116 participants at risk
Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.8%
15/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
19.8%
23/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
Nervous system disorders
Dizziness
|
9.4%
11/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
5.2%
6/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
Vascular disorders
Flushing
|
15.4%
18/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
22.4%
26/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
9/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
5.2%
6/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
Cardiac disorders
Angina pectoris
|
3.4%
4/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
7.8%
9/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
General disorders
Chest discomfort
|
9.4%
11/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
7.8%
9/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
13/117 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
8.6%
10/116 • Treatment-emergent adverse events (TEAEs) were defined as adverse events observed from the time of administration of regadenoson to 24 hours after last study drug administration within each modality, i.e. from Day 1 to Day 3.
Safety Analysis Set composed of all randomized patients who received at least 1 dose of regadenoson.
|
Additional Information
Senior Medical Director, Medical Affairs
Astellas Scientific and Medical Affairs, Inc. / Astellas Pharma Global Development, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER