Allergic-like Reactions to the MR Imaging Contrast Agent Gadobutrol: A Prospective Study of 32 991 Consecutive Injections
Bibliographic record
Abstract
Purpose To determine the frequency and severity of allergic-like reactions to gadobutrol. Materials and Methods Data collection during the study period was part of a hospital quality assurance initiative to confirm the safety of gadobutrol after its introduction at this institute from 2010 to 2013. The study also included an electronic health records review approved by the institutional review board of the University Health Network, Toronto. The institutional review board waived the requirement for informed consent. At the time of each reaction to contrast material, the patient's age and sex, whether premedication was given, the contrast agent used, the volume injected, the patient's symptoms, and the treatment administered were recorded. Allergic-like reactions from physiologic reactions were differentiated and the frequency and severity of allergic-like reactions, the prevalence of risk factors for reactions, the frequency of reactions despite the use of premedication (a "breakthrough reaction"), and the frequency of delayed reactions were calculated. A χ(2) test to determine whether there was a difference in reaction rates during the 4 years of the study was performed. Results The frequency of allergic-like reactions to gadobutrol was 0.32% (96 reactions among 30 373 gadobutrol-enhanced magnetic resonance [MR] imaging examinations) during the study period. These 96 reactions occurred in 82 patients. There was only one severe reaction. There were identifiable risk factors in 40 of the 82 patients (48.8%). Of the 82 patients with an allergic-like reaction, 28 (34.1%) received a gadolinium-based contrast agent before and had no reaction. A total of 12 of 33 (36.4%) breakthrough reactions occurred, and there were 15 of 96 (15.6%) reactions with a delayed onset. Conclusion The frequency of allergic-like reactions to gadobutrol is very low, accounting for 96 reactions among 30 373 gadobutrol-enhanced MR imaging examinations (0.32%), and severe reactions are rare. In patients who experience a reaction, breakthrough reactions and delayed reactions are relatively common. (©) RSNA, 2016.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".