Trial Outcomes & Findings for Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration (NCT NCT01467271)

Last Updated: 2019-02-04

Results Overview

Recruitment status

COMPLETED

Target enrollment

540 participants

Primary outcome timeframe

All patients were followed up during 2 years after Dotarem administration.

Results posted on

2019-02-04

Participant milestones
Measure	All Included Patients All patients included in the study.
Overall Study STARTED	540
Overall Study COMPLETED	338
Overall Study NOT COMPLETED	202

Reasons for withdrawal
Measure	All Included Patients All patients included in the study.
Overall Study Death	84
Overall Study Lost to Follow-up	83
Overall Study Retraction of patient's consent	21
Overall Study Other reason	14

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Safety Population n=539 Participants The safety population included all patients receiving at least one injection of contrast media regardless of the quantity.
Age, Continuous	69.7 years STANDARD_DEVIATION 12.7 • n=539 Participants
Sex: Female, Male Female	224 Participants n=539 Participants
Sex: Female, Male Male	315 Participants n=539 Participants
Region of Enrollment Colombia	15 participants n=539 Participants
Region of Enrollment South Korea	117 participants n=539 Participants
Region of Enrollment Argentina	2 participants n=539 Participants
Region of Enrollment Turkey	50 participants n=539 Participants
Region of Enrollment Belgium	121 participants n=539 Participants
Region of Enrollment United States	76 participants n=539 Participants
Region of Enrollment Italy	37 participants n=539 Participants
Region of Enrollment United Kingdom	9 participants n=539 Participants
Region of Enrollment France	23 participants n=539 Participants
Region of Enrollment Germany	77 participants n=539 Participants
Region of Enrollment Spain	12 participants n=539 Participants

Timeframe: All patients were followed up during 2 years after Dotarem administration.

Outcome measures
Measure	NSF Population n=446 Participants The NSF population included patients with the NSF follow-up questionnaire completed.
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Guerbet

Phone: +33(0)1 45 91 50 00

Restriction type: OTHER