Trial Outcomes & Findings for Coronary MDCTA With Iopamidol Injection 370 (NCT NCT00558792)

NCT ID: NCT00558792

Last Updated: 2012-10-24

Results Overview

For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 210 participants
• Primary outcome timeframe: Immediately post dose
• Results posted on: 2012-10-24

Participant Flow

Patients were enrolled from December 2007 to December 2009 in 17 investigational sites across the United States of America (USA), 2 investigational sites in Canada and 2 investigational sites in Italy. A blinded read of the images obtained during the study was performed in May 2010.

This was a Phase II, multicenter, prospective, double-blind, randomized, parallel-group comparison of 3 doses of iopamidol injection 370 when used for coronary MDCTA.

Participant milestones

Measure	Isovue 370, 70 mL iopamidol injection 370, 70 mL	Isovue 370, 80 mL iopamidol injection 370, 80 mL	Isovue 370, 90 mL iopamidol injection 370, 90 mL
Overall Study STARTED	68	63	60
Overall Study COMPLETED	68	63	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coronary MDCTA With Iopamidol Injection 370

Baseline characteristics by cohort

Measure	Isovue 370, 70 mL n=68 Participants iopamidol injection 370, 70 mL	Isovue 370, 80 mL n=63 Participants iopamidol injection 370, 80 mL	Isovue 370, 90 mL n=60 Participants iopamidol injection 370, 90 mL	Total n=191 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	49 Participants n=7 Participants	42 Participants n=5 Participants	144 Participants n=4 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	47 Participants n=4 Participants
Age Continuous	57.7 years STANDARD_DEVIATION 8.85 • n=5 Participants	57.7 years STANDARD_DEVIATION 8.54 • n=7 Participants	58.7 years STANDARD_DEVIATION 9.25 • n=5 Participants	58.0 years STANDARD_DEVIATION 8.85 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	21 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	118 Participants n=4 Participants
Region of Enrollment United States	55 participants n=5 Participants	50 participants n=7 Participants	48 participants n=5 Participants	153 participants n=4 Participants
Region of Enrollment Canada	11 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	31 participants n=4 Participants
Region of Enrollment Italy	2 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately post dose

For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.

Outcome measures

Measure	Isovue 370, 70 mL n=963 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=865 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=848 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1	949 Segments Visualized Accurately	842 Segments Visualized Accurately	841 Segments Visualized Accurately

PRIMARY outcome

Timeframe: Immediately post dose

For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.

Outcome measures

Measure	Isovue 370, 70 mL n=1042 Segments Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=950 Segments Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=927 Segments Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2	1032 Segments Visualized Accurately	924 Segments Visualized Accurately	927 Segments Visualized Accurately

PRIMARY outcome

Timeframe: Immediately post dose

For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.

Outcome measures

Measure	Isovue 370, 70 mL n=925 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=826 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=817 Segments Present & Technically Adequate Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3	925 Segments Visualized Accurately	824 Segments Visualized Accurately	817 Segments Visualized Accurately

PRIMARY outcome

Timeframe: Immediately post dose

For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.

Outcome measures

Measure	Isovue 370, 70 mL n=67 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=58 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=59 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Contrast Density (CD) Measurements, Off-Site Reader 1	372.806 Hounsfield Units Standard Deviation 90.5842	398.255 Hounsfield Units Standard Deviation 82.3593	418.197 Hounsfield Units Standard Deviation 97.4072

PRIMARY outcome

Timeframe: Immediately post dose

For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.

Outcome measures

Measure	Isovue 370, 70 mL n=67 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=58 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=58 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Contrast Density (CD) Measurements, Off-Site Reader 2	364.784 Hounsfield Units Standard Deviation 78.2154	396.291 Hounsfield Units Standard Deviation 85.7038	413.665 Hounsfield Units Standard Deviation 86.0972

PRIMARY outcome

Timeframe: Immediately post dose

For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.

Outcome measures

Measure	Isovue 370, 70 mL n=64 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=58 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=57 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Contrast Density (CD) Measurements, Off-Site Reader 3	363.071 Hounsfield Units Standard Deviation 85.7795	383.841 Hounsfield Units Standard Deviation 96.8142	406.206 Hounsfield Units Standard Deviation 91.9117

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity	63.6 Sensitivity (%)	65.5 Sensitivity (%)	77.8 Sensitivity (%)

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity	98.3 Specificity (%)	95.2 Specificity (%)	96.6 Specificity (%)

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity	68.2 Sensitivity (%)	79.3 Sensitivity (%)	66.7 Sensitivity (%)

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity	94.5 Specificity (%)	92.1 Specificity (%)	90.7 Specificity (%)

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity	59.1 Sensitivity (%)	62.1 Sensitivity (%)	66.7 Sensitivity (%)

PRIMARY outcome

Timeframe: Immediately post dose

Population: Number of participants with significant disease (\>50% stenosis)

For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.

Outcome measures

Measure	Isovue 370, 70 mL n=257 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=218 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=232 Vessels Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity	94.9 Specificity (%)	91.5 Specificity (%)	90.7 Specificity (%)

SECONDARY outcome

Timeframe: up to 72 hours post dose

Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.

Outcome measures

Measure	Isovue 370, 70 mL n=68 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 80 mL n=63 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.	Isovue 370, 90 mL n=60 Participants Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater	15 Participants who Experienced AE(s)	14 Participants who Experienced AE(s)	13 Participants who Experienced AE(s)

Adverse Events

Isovue 370, 70 mL

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Isovue 370, 80 mL

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Isovue 370, 90 mL

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Isovue 370, 70 mL n=68 participants at risk iopamidol injection 370, 70 mL	Isovue 370, 80 mL n=63 participants at risk iopamidol injection 370, 80 mL	Isovue 370, 90 mL n=60 participants at risk iopamidol injection 370, 90 mL
General disorders Feeling Hot	8.8% 6/68 • Number of events 6 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	7.9% 5/63 • Number of events 5 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	8.3% 5/60 • Number of events 5 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.
Vascular disorders Flushing	5.9% 4/68 • Number of events 4 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	6.3% 4/63 • Number of events 4 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	8.3% 5/60 • Number of events 5 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.
Nervous system disorders Headache	10.3% 7/68 • Number of events 7 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	9.5% 6/63 • Number of events 6 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	3.3% 2/60 • Number of events 2 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.
General disorders Injection Site Erythema	0.00% 0/68 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	7.9% 5/63 • Number of events 5 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.	1.7% 1/60 • Number of events 1 • Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370. Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.

Additional Information

Usha Halemane, Executive Director of Medical Biometrics and Medical Writing

Bracco Diagnostics Inc

Phone: 609-514-2578

Email: usha.halemane@diag.bracco.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
• Publication restrictions are in place

Restriction type: OTHER