Trial Outcomes & Findings for Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis (NCT NCT01254552)
NCT ID: NCT01254552
Last Updated: 2019-05-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
351 participants
Primary outcome timeframe
From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
Results posted on
2019-05-31
Participant Flow
Participant milestones
| Measure |
Dotarem and Xenetix 350
All patients were planned to undergo a MRI examination with Dotarem and a myocardial CCTA examination with Xenetix 350 to evaluate his/her coronary and cardiac status.
|
|---|---|
|
Screening Visit
STARTED
|
351
|
|
Screening Visit
COMPLETED
|
348
|
|
Screening Visit
NOT COMPLETED
|
3
|
|
Delayed-enhanced MRI With Dotarem
STARTED
|
348
|
|
Delayed-enhanced MRI With Dotarem
COMPLETED
|
328
|
|
Delayed-enhanced MRI With Dotarem
NOT COMPLETED
|
20
|
|
CCTA With Xenetix 350
STARTED
|
328
|
|
CCTA With Xenetix 350
COMPLETED
|
322
|
|
CCTA With Xenetix 350
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Baseline characteristics by cohort
| Measure |
All Included Patients
n=348 Participants
All patients included in the study.
|
|---|---|
|
Age, Continuous
|
60.18 years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)Outcome measures
| Measure |
Intention To Treat Population
n=322 Participants
All patients with a valid MRI and CCTA examinations.
|
Patients With at Least One Occult Myocardial Scar
Patients with at least one Occult Myocardial Scar on cardiac MRI
|
|---|---|---|
|
Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)The degree of coronary artery stenosis on CCTA was assessed according to the following scale: * No stenosis: 0% * Non significant stenosis: 1-50% * Significant stenosis \>50% and ≤99% * Occlusion: 100%
Outcome measures
| Measure |
Intention To Treat Population
n=299 Participants
All patients with a valid MRI and CCTA examinations.
|
Patients With at Least One Occult Myocardial Scar
n=23 Participants
Patients with at least one Occult Myocardial Scar on cardiac MRI
|
|---|---|---|
|
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
No stenosis: 0%
|
80 Participants
|
2 Participants
|
|
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Non-significant stenosis: 1-50%
|
152 Participants
|
8 Participants
|
|
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Significant stenosis: >50% and ≤99%
|
61 Participants
|
12 Participants
|
|
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Occlusion: 100%
|
6 Participants
|
1 Participants
|
Adverse Events
Between Dotarem and Xenetix 350 Injection
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
During Xenetix 350 Injection
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
After Xenetix 350 Injection
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Between Dotarem and Xenetix 350 Injection
n=328 participants at risk
Adverse events that occurred after Dotarem injection (MRI examination) and before Xenetix 350 injection (CCTA examination)
|
During Xenetix 350 Injection
n=328 participants at risk
Adverse events that occurred during injection of Xenetix 350 (CCTA examination)
|
After Xenetix 350 Injection
n=328 participants at risk
Adverse events that occurred after the injection of Xenetix 350 (CCTA examination)
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.91%
3/328 • Number of events 3 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.61%
2/328 • Number of events 2 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Nervous system disorders
Headache
|
0.61%
2/328 • Number of events 2 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Investigations
Blood pressure increased
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Investigations
Heart rate increased
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Infections and infestations
Bronchitis
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
General disorders
Injection site pain
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.91%
3/328 • Number of events 3 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
General disorders
Extravasation
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
General disorders
Pyrexia
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.61%
2/328 • Number of events 2 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.61%
2/328 • Number of events 2 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.61%
2/328 • Number of events 2 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
|
Eye disorders
Visual impairment
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.00%
0/328 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
0.30%
1/328 • Number of events 1 • From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
|
Additional Information
Corinne Dubourdieu, Head of Clinical Projects and Medical Writing
Guerbet
Phone: +33(0)1 45 91 50 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER