PMID- 14696230
OWN - NLM
STAT- MEDLINE
DCOM- 20040506
LR  - 20171116
IS  - 1053-1807 (Print)
IS  - 1053-1807 (Linking)
VI  - 19
IP  - 1
DP  - 2004 Jan
TI  - Safety assessment of gadoversetamide (OptiMARK) administered by power injector.
PG  - 133-40
AB  - PURPOSE: To evaluate the safety of OptiMARK (gadoversetamide injection) 
      administered via power injector. MATERIALS AND METHODS: The study population 
      included 144 healthy volunteers aged 18 years or older randomly assigned to one 
      of seven treatment groups (N = 20/group). The safety assessment was based on 
      changes in physical examination, vital signs, electrocardiograms (ECGs), standard 
      clinical laboratory tests, and adverse events (AEs) through a 24-hour 
      postinjection period. RESULTS: OptiMARK caused no serious AEs or unexpected 
      changes in physical examinations or laboratory parameters. The changes observed 
      in vital signs and ECG intervals did not vary with changes in injection rate and 
      were not significantly (P < 0.05) different from those elicited by saline 
      administration at the same rates. CONCLUSION: This study demonstrated the safety 
      of OptiMARK when administered via a power injector at rates of 2, 4, and 6 
      mL/second.
CI  - Copyright 2003 Wiley-Liss, Inc.
FAU - Abdou, Nancy
AU  - Abdou N
AD  - Quintiles Phase 1 Services, Lenexa, Kansas, USA.
FAU - Napoli, Alicia M
AU  - Napoli AM
FAU - Hynes, Michael R
AU  - Hynes MR
FAU - Allen, John C Jr
AU  - Allen JC Jr
FAU - Wible, James H Jr
AU  - Wible JH Jr
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Magn Reson Imaging
JT  - Journal of magnetic resonance imaging : JMRI
JID - 9105850
RN  - 0 (Contrast Media)
RN  - 0 (Organometallic Compounds)
RN  - RLM74T3Z9D (gadoversetamide)
SB  - IM
MH  - Analysis of Variance
MH  - Contrast Media/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Injections, Intravenous/methods
MH  - *Magnetic Resonance Imaging
MH  - Male
MH  - Organometallic Compounds/*administration & dosage/adverse effects
MH  - Poisson Distribution
MH  - Safety
EDAT- 2003/12/30 05:00
MHDA- 2004/05/07 05:00
CRDT- 2003/12/30 05:00
PHST- 2003/12/30 05:00 [pubmed]
PHST- 2004/05/07 05:00 [medline]
PHST- 2003/12/30 05:00 [entrez]
AID - 10.1002/jmri.10439 [doi]
PST - ppublish
SO  - J Magn Reson Imaging. 2004 Jan;19(1):133-40. doi: 10.1002/jmri.10439.