Trial Outcomes & Findings for Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) (NCT NCT01010932)

NCT ID: NCT01010932

Last Updated: 2016-06-16

Results Overview

Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 222 participants
• Primary outcome timeframe: 2 - 28 days
• Results posted on: 2016-06-16

Participant Flow

First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments

A total of 222 patients fulfilling the eligibility criteria were enrolled, of which 200 patients received Dotarem and completed the study. Twenty-two patients did not receive Dotarem and were discontinued prematurely.

Participant milestones

Measure	TOF MRA Followed by Dotarem-enhanced MRA Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA. Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.
Overall Study STARTED	222
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Baseline characteristics by cohort

Measure	TOF MRA Followed by Dotarem-enhanced MRA n=222 Participants Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA. Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=5 Participants
Age, Categorical >=65 years	114 Participants n=5 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants
Region of Enrollment Colombia	35 participants n=5 Participants
Region of Enrollment Argentina	48 participants n=5 Participants
Region of Enrollment Mexico	18 participants n=5 Participants
Region of Enrollment Korea, Republic of	39 participants n=5 Participants
Region of Enrollment Chile	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 - 28 days

Population: For 2 patients, MRA images were not analyzed because images were incomplete.

Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).

Outcome measures

Measure	Dotarem-enhanced MRA n=2772 arterial segments Patients benefiting from an MRA after Dotarem IV administration	TOF MRA n=2772 arterial segments Patients benefiting from an MRA with no contrast medium administration
Technical Failure Rate Reader 1	4.65 percentage of arterial segments Interval 3.87 to 5.44	29.44 percentage of arterial segments Interval 27.74 to 31.13
Technical Failure Rate Reader 2	1.77 percentage of arterial segments Interval 1.28 to 2.26	16.70 percentage of arterial segments Interval 15.31 to 18.09
Technical Failure Rate Reader 3	2.20 percentage of arterial segments Interval 1.65 to 2.75	18.54 percentage of arterial segments Interval 17.1 to 19.99

PRIMARY outcome

Timeframe: 2-42 days

Population: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.

Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).

Outcome measures

Measure	Dotarem-enhanced MRA n=2686 number of arterial segments Patients benefiting from an MRA after Dotarem IV administration	TOF MRA n=2686 number of arterial segments Patients benefiting from an MRA with no contrast medium administration
Sensitivity Reader 2	63.08 percentage of stenotic segments Interval 51.34 to 74.81	63.08 percentage of stenotic segments Interval 51.34 to 74.81
Sensitivity Reader 1	58.46 percentage of stenotic segments Interval 46.48 to 70.44	53.85 percentage of stenotic segments Interval 41.73 to 65.97
Sensitivity Reader 3	53.85 percentage of stenotic segments Interval 41.73 to 65.97	49.23 percentage of stenotic segments Interval 37.08 to 61.38

PRIMARY outcome

Timeframe: 2 - 42 days

Population: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.

Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).

Outcome measures

Measure	Dotarem-enhanced MRA n=2686 Number of arterial segments Patients benefiting from an MRA after Dotarem IV administration	TOF MRA n=2686 Number of arterial segments Patients benefiting from an MRA with no contrast medium administration
Specificity Reader 1	98.13 percentage of non-stenotic segments Interval 97.61 to 98.65	85.43 percentage of non-stenotic segments Interval 84.07 to 86.78
Specificity Reader 2	98.51 percentage of non-stenotic segments Interval 98.05 to 98.98	90.39 percentage of non-stenotic segments Interval 89.26 to 91.51
Specificity Reader 3	98.63 percentage of non-stenotic segments Interval 98.18 to 99.07	90.42 percentage of non-stenotic segments Interval 89.3 to 91.55

Adverse Events

Dotarem MRA

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

TOF MRA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Computerized Tomography Angiography (CTA)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Patients Discontinued Without Dotarem Administration

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dotarem MRA n=200 participants at risk Patients benefiting from a MR angiography after an IV administration of Dotarem	TOF MRA n=200 participants at risk Patients benefiting from a MR angiography with no contrast medium administration	Computerized Tomography Angiography (CTA) n=200 participants at risk Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium	Patients Discontinued Without Dotarem Administration n=22 participants at risk Patients withdrawn before administration of Dotarem whatever the reason
Nervous system disorders Carotid artery stenosis	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
General disorders Chest Pain	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Renal and urinary disorders Renal Failure	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	4.5% 1/22 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Hepatobiliary disorders Cholelithiasis	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.

Other adverse events

Measure	Dotarem MRA n=200 participants at risk Patients benefiting from a MR angiography after an IV administration of Dotarem	TOF MRA n=200 participants at risk Patients benefiting from a MR angiography with no contrast medium administration	Computerized Tomography Angiography (CTA) n=200 participants at risk Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium	Patients Discontinued Without Dotarem Administration n=22 participants at risk Patients withdrawn before administration of Dotarem whatever the reason
General disorders Injection site hematoma	1.0% 2/200 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Investigations Alanine aminotransferase increased	1.0% 2/200 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Gastrointestinal disorders Nausea	1.5% 3/200 • Number of events 4 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Nervous system disorders Dizziness	1.0% 2/200 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Vascular disorders Hypertension	1.5% 3/200 • Number of events 3 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	1.0% 2/200 • Number of events 2 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Nervous system disorders Headache	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	1.5% 3/200 • Number of events 3 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/22 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Investigations Neutrophil Count increased	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	4.5% 1/22 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Investigations Lymphopenia	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.50% 1/200 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	4.5% 1/22 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
Nervous system disorders Transient Ischemic Attack	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	0.00% 0/200 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.	4.5% 1/22 • Number of events 1 • Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days. Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.

Additional Information

Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs

Guerbet

Phone: +33 1 45 91 50 00

Email: pierre.desche@guerbet-group.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60