PMID- 9204350
OWN - NLM
STAT- MEDLINE
DCOM- 19970728
LR  - 20200330
IS  - 0938-7994 (Print)
IS  - 0938-7994 (Linking)
VI  - 7 Suppl 4
DP  - 1997
TI  - Evaluation of iopentol (Imagopaque 350) in CT enhancement. A multi-centre 
      monitoring trial assessing adverse events and diagnostic information--results 
      from 1,823 patients in France.
PG  - S109-14
AB  - OBJECTIVES: To evaluate the safety and efficacy of iopentol 350 mg I/ml 
      (Imagopaque/Ivepaque, Nycomed Imaging AS, Oslo, Norway), a monomeric non-ionic 
      contrast medium for computed tomography, in a large population. To identify 
      predictive factors for patient safety. MATERIALS AND METHODS: One thousand eight 
      hundred and twenty-three (1,823) patients from 48 centres in France were included 
      during a 5-month period. Safety was evaluated by registering adverse events (AEs) 
      reported by the patients, and data were analysed using a multiple factor model. 
      RESULTS: Only 2.6% of the patients experienced AEs other than discomfort. There 
      were no serious AEs. Overall, AEs were more frequent in patients under 50 years 
      of age, in women, and in patients who received contrast medium as a single bolus. 
      Contrast enhancement was considered adequate or better in 98.9% of the patients. 
      A large variation in discomfort (local warmth/chill or pain) frequency was seen 
      between centres, ranging from 0% to 81%. This result implies that factors other 
      than the CM influence the incidence of discomfort. CONCLUSIONS: This first study 
      in a large population shows that iopentol 350 mg I/ml is well tolerated and 
      provides CT images of excellent, good or adequate quality in the vast majority of 
      patients. Age, sex and injection procedure were shown to be independent 
      predictors in the AE survey.
FAU - Oxaal, M
AU  - Oxaal M
AD  - Nycomed Imaging AS, Oslo, Norway.
FAU - Lambrechts, M
AU  - Lambrechts M
FAU - Bunouf, P
AU  - Bunouf P
FAU - Menuet, J F
AU  - Menuet JF
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - Germany
TA  - Eur Radiol
JT  - European radiology
JID - 9114774
RN  - 0 (Contrast Media)
RN  - 0 (Triiodobenzoic Acids)
RN  - 7D6XWX076T (iopentol)
SB  - IM
MH  - Contrast Media/*adverse effects
MH  - Drug Packaging
MH  - Evaluation Studies as Topic
MH  - Female
MH  - France
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Risk Factors
MH  - Safety
MH  - *Tomography, X-Ray Computed
MH  - Triiodobenzoic Acids/*adverse effects
EDAT- 1997/01/01 00:00
MHDA- 1997/01/01 00:01
CRDT- 1997/01/01 00:00
PHST- 1997/01/01 00:00 [pubmed]
PHST- 1997/01/01 00:01 [medline]
PHST- 1997/01/01 00:00 [entrez]
AID - 10.1007/pl00006874 [doi]
PST - ppublish
SO  - Eur Radiol. 1997;7 Suppl 4:S109-14. doi: 10.1007/pl00006874.