Yoshito Tsushima1, Kazuo Awai2, Gen Shinoda3, Hiroyuki Miyoshi3, Masayuki Chosa4, Toshiyuki Sunaya5, Jan Endrikat6,7. 1. Department of Diagnostic Radiology and Nuclear Medicine, Gunma University Graduate School of Medicine, 3-39-22 Showa, Maebashi, 373-8511, Gunma, Japan. yoshitotsushima@gunma-u.ac.jp. 2. Department of Diagnostic Radiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8511, Japan. 3. Medical Affairs Radiology, Bayer Yakuhin, Ltd, 2-4-9 Kita-ku, Umeda, Osaka, 530-0001, Japan. 4. Pharmacovigilance PMS, Bayer Yakuhin, Ltd, 2-4-9 Kita-ku, Umeda, Osaka, 530-0001, Japan. 5. Product Development, Clinical Statistics, Bayer Yakuhin, Ltd, 2-4-9 Kita-ku, Umeda, Osaka, 530-0001, Japan. 6. Radiology, Bayer AG, Müllerstraße 178, 13353, Berlin, Germany. 7. Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.
Abstract
PURPOSE: To evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan. MATERIALS AND METHODS: Gadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection. RESULTS: Questionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4 years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02 mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1 h post-injection)-including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations. CONCLUSION: Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.
PURPOSE: To evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan. MATERIALS AND METHODS:Gadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection. RESULTS: Questionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4 years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02 mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1 h post-injection)-including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations. CONCLUSION:Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.
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