Trial Outcomes & Findings for Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (NCT NCT01255722)

Last Updated: 2015-12-16

Results Overview

Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic. A patient's CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

468 participants

Primary outcome timeframe

< 24h

Results posted on

2015-12-16

Participant Flow

A total of 468 patients from 5 European countries were enrolled and evaluated between 3 November 2010 and 17 September 2012.

Participant milestones

Participant milestones
Measure	Iobitridol Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide Patients were IV injected with a single dose of iopromide before a coronary CT angiography	Iomeprol Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Overall Study STARTED	155	160	153
Overall Study COMPLETED	152	159	152
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Iobitridol Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide Patients were IV injected with a single dose of iopromide before a coronary CT angiography	Iomeprol Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Overall Study Adverse Event	0	1	1
Overall Study asymptomatic patient	1	0	0
Overall Study beta-blocker contraindicated	2	0	0

Baseline Characteristics

Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iobitridol n=155 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=160 Participants Patients were IV injected with a single dose of iopromide before a coronary CT angiography	Iomeprol n=153 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography	Total n=468 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	104 Participants n=5 Participants	101 Participants n=7 Participants	108 Participants n=5 Participants	313 Participants n=4 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	59 Participants n=7 Participants	45 Participants n=5 Participants	155 Participants n=4 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 12.2 • n=5 Participants	58.7 years STANDARD_DEVIATION 11.6 • n=7 Participants	56.9 years STANDARD_DEVIATION 13.4 • n=5 Participants	57.8 years STANDARD_DEVIATION 12.4 • n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	68 Participants n=7 Participants	65 Participants n=5 Participants	198 Participants n=4 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	92 Participants n=7 Participants	88 Participants n=5 Participants	270 Participants n=4 Participants
Region of Enrollment France	59 participants n=5 Participants	61 participants n=7 Participants	59 participants n=5 Participants	179 participants n=4 Participants
Region of Enrollment Spain	21 participants n=5 Participants	21 participants n=7 Participants	20 participants n=5 Participants	62 participants n=4 Participants
Region of Enrollment Germany	41 participants n=5 Participants	45 participants n=7 Participants	41 participants n=5 Participants	127 participants n=4 Participants
Region of Enrollment Switzerland	9 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	28 participants n=4 Participants
Region of Enrollment Italy	25 participants n=5 Participants	24 participants n=7 Participants	23 participants n=5 Participants	72 participants n=4 Participants

PRIMARY outcome

Timeframe: < 24h

Population: Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment	92.1 Percentage of patients Standard Error 2.2	95.4 Percentage of patients Standard Error 1.7	94.6 Percentage of patients Standard Error 1.8

SECONDARY outcome

Timeframe: <24h

Population: Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.

For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Average Image Quality According to Off-site Reading	3.5 Image quality Score on a scale Standard Deviation 0.9	3.5 Image quality Score on a scale Standard Deviation 0.8	3.4 Image quality Score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: <24h

Population: Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.

A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Coronary Track Rate	10.9 Number of tracked segments per patient Standard Deviation 2.2	10.8 Number of tracked segments per patient Standard Deviation 2.4	11.1 Number of tracked segments per patient Standard Deviation 2.3

SECONDARY outcome

Timeframe: <1h

Population: Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.

Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Average Signal Attenuation After IV Injection of Contrast	426.3 Hounsfield Units Standard Deviation 92.9	449.8 Hounsfield Units Standard Deviation 88.1	466.4 Hounsfield Units Standard Deviation 104.6

SECONDARY outcome

Timeframe: <1h

Population: Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.

Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories. A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula: SNR Territory = Post Attenuation / Image Noise

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Average Signal-to-Noise Ratio (Average SNR)	16.2 Hounsfield Units:Hounsfield Units Standard Deviation 5.6	17.1 Hounsfield Units:Hounsfield Units Standard Deviation 5.0	17.6 Hounsfield Units:Hounsfield Units Standard Deviation 6.6

SECONDARY outcome

Timeframe: <1h

Population: Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.

Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU). A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air. In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att - Baseline Att) / Image Noise

Outcome measures

Outcome measures
Measure	Iobitridol n=151 Participants Patients were IV injected with a single dose of iobitridol before a coronary CT angiography	Iopromide n=152 Participants Patients were IV injected with a single dose of iopromide before coronary CT angiography	Iomeprol n=149 Participants Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Average Contrast-to-noise Ratio (Average CNR)	14.4 Hounsfield Units:Hounsfield Units Standard Deviation 5.4	15.3 Hounsfield Units:Hounsfield Units Standard Deviation 4.8	15.8 Hounsfield Units:Hounsfield Units Standard Deviation 6.5

Adverse Events

Iobitridol

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Iopromide

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Iomeprol

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iobitridol n=152 participants at risk Patients were IV injected with a single dose of iobitridol before a coronary CT angiography iobitridol: single IV injection	Iopromide n=159 participants at risk Patients were IV injected with a single dose of iopromide before a coronary CT angiography iopromide: Single IV injection	Iomeprol n=152 participants at risk Patients were IV injected with a single dose of iomeprol before a coronary CT angiography iomeprol: Single IV injection
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/159 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.66% 1/152 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).

Other adverse events

Other adverse events
Measure	Iobitridol n=152 participants at risk Patients were IV injected with a single dose of iobitridol before a coronary CT angiography iobitridol: single IV injection	Iopromide n=159 participants at risk Patients were IV injected with a single dose of iopromide before a coronary CT angiography iopromide: Single IV injection	Iomeprol n=152 participants at risk Patients were IV injected with a single dose of iomeprol before a coronary CT angiography iomeprol: Single IV injection
Cardiac disorders Bradycardia	7.2% 11/152 • Number of events 12 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	10.1% 16/159 • Number of events 17 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	7.9% 12/152 • Number of events 13 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Cardiac disorders Extrasystoles	7.2% 11/152 • Number of events 11 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	4.4% 7/159 • Number of events 8 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	4.6% 7/152 • Number of events 7 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Nervous system disorders Headache	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	1.3% 2/159 • Number of events 2 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	2.0% 3/152 • Number of events 3 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
General disorders Injection Site Pain	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	1.9% 3/159 • Number of events 3 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	1.3% 2/152 • Number of events 2 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
General disorders Pain	1.3% 2/152 • Number of events 2 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/159 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.63% 1/159 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.66% 1/152 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	1.3% 2/159 • Number of events 2 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Cardiac disorders Arrythmia	0.66% 1/152 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/159 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
General disorders Feeling hot	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/159 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.66% 1/152 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Gastrointestinal disorders Nausea	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.63% 1/159 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Nervous system disorders Presyncope	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.63% 1/159 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/159 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.66% 1/152 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).
Cardiac disorders Tachycardia	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.63% 1/159 • Number of events 1 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).	0.00% 0/152 • Post-injection adverse events (i.e. treatment-emergent adverse events) were reported from the time of injection of the contrast media up to 30 minutes after the end of the CT scan exam. The Official French Method of Causality Assessment was used (Begaud B et al. 'Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France'. Therapy. 1985;40:111-8).

Additional Information

Prof. Dr. med. Martin HOFFMANN

Section Head Interventional and Cardiac Radiology - Kantonsspital Lucerne, Spitalstrasse, 6006 Lucerne, Switzerland

Phone: +41 41 205 4660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No unpublished data given to the investigator may be transmitted to a third party without prior approval of the sponsor in writing. The data are the exclusive property of Guerbet. The investigator undertakes to submit to Guerbet any draft articles or papers related to this study within 30 days of their submission to the scientific review or the congress scientific committee. All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.
Publication restrictions are in place

Restriction type: OTHER