Mahajan Harsh, Batta Nafisa S, Vaze Pravin, Shad Pratibha S, Mahajan Kabir, Hibberd Mark G, Roessink Burkhard, Dunham Dustin M, Sahni Jasmeet, Pandey Rohini
Radiology, Mahajan Imaging Pvt Ltd, Delhi, IND.
Radiodiagnosis, Mahajan Imaging Pvt Ltd, Delhi, IND.
Cureus. 2025 Jul 31;17(7):e89184. doi: 10.7759/cureus.89184. eCollection 2025 Jul.
This study aimed to conduct a single-arm, open-label, multicenter postmarketing surveillance study to evaluate the safety of Omniscan immediately and six weeks (± two weeks) after injection.
Three sites in India that use Omniscan (gadodiamide; GE Healthcare, Chicago, IL) as a contrast agent were selected. Omniscan is a linear, nonionic, nonprotein-binding gadolinium-based contrast agent. A total of 150 study participants were enrolled for contrast-enhanced magnetic resonance imaging (CE-MRI). All patients were asked for permission to be contacted six weeks (± two weeks) after CE-MRI, and participants were telephonically followed up by a healthcare professional with a questionnaire.
Of the 150 enrolled participants, 133 (89%) completed the telephonic follow-up, scheduled for six weeks (± two weeks) after injection. Of these 133 participants, a total of seven (5.26%) treatment-emergent adverse events (TEAEs) were reported. Out of these seven TEAEs, one TEAE (0.007%) was serious, with seriousness criteria life-threatening. A single event was severe; the remaining adverse events (AEs) were of mild severity. None of the AEs was assessed as related to Omniscan.
There were no AEs causally related to Omniscan (gadodiamide) immediately after injection and during telephonic follow-up after six weeks (± two weeks). Safety analysis in this postmarketing surveillance did not reveal any increase in the safety risk of Omniscan. No AE persisted for four weeks or more after injection of Omniscan for MRI. CE-MRI with Omniscan was thus generally considered safe and well-tolerated.
本研究旨在开展一项单臂、开放标签、多中心上市后监测研究，以评估注射后即刻及六周（±两周）使用欧乃影的安全性。
选取印度使用欧乃影（钆双胺；通用电气医疗集团，伊利诺伊州芝加哥）作为造影剂的三个地点。欧乃影是一种线性、非离子、非蛋白结合的钆基造影剂。共招募150名研究参与者进行对比增强磁共振成像（CE-MRI）。所有患者均被询问是否允许在CE-MRI后六周（±两周）进行联系，研究参与者由一名医疗专业人员通过电话进行问卷调查随访。
在150名登记参与者中，133名（89%）完成了预定在注射后六周（±两周）进行的电话随访。在这133名参与者中，共报告了7例（5.26%）治疗中出现的不良事件（TEAE）。在这7例TEAE中，1例TEAE（0.007%）为严重不良事件，严重程度标准为危及生命。仅有1例为重度不良事件；其余不良事件（AE）为轻度。没有AE被评估为与欧乃影相关。
注射后即刻及六周（±两周）电话随访期间，未发现与欧乃影（钆双胺）有因果关系的AE。本次上市后监测中的安全性分析未显示欧乃影的安全风险有任何增加。注射欧乃影进行MRI检查后，没有AE持续四周或更长时间。因此，使用欧乃影进行CE-MRI总体上被认为是安全且耐受性良好的。
