What question did this study set out to answer?

To evaluate the safety profile, adverse reaction rates, and laboratory parameter changes associated with intravenous gadopentetate dimeglumine in adult clinical trials.

January 1, 1990Radiology

Safety assessment of gadopentetate dimeglumine in U.S. clinical trials.

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Authors

HGH A GoldsteinSpecialty Materials (United States)FKFranciska K. KashanianMemorial Sloan Kettering Cancer Center RBR F BlumettiSpecialty Materials (United States)

Discussion

Member takes

Implication

Clinical trial analysis demonstrates high tolerance and minimal adverse effects in adults receiving MRI contrast, suggesting robust safety.

Key Points

To evaluate the safety profile, adverse reaction rates, and laboratory parameter changes associated with intravenous gadopentetate dimeglumine in adult clinical trials.
Analyzed pooled adverse reaction records, laboratory values, and diagnostic assessments from N=1,068 adult patients receiving gadopentetate dimeglumine in United States clinical trials.
Assessed hematologic, blood chemistry, urinary parameters, electrocardiograms, electroencephalograms, neurologic exams, and vital signs before and after administration.
Clinical adverse reactions occurred in 213 of 1,068 patients (19.9%), with the majority described as minor and short-lived.
Hematologic, urinalysis, and chemistry panels showed no drug-related toxicities, apart from a transient, asymptomatic increase in serum iron and bilirubin levels in some patients.
Electrocardiography, electroencephalography, neurologic examinations, and vital signs demonstrated no clinically significant trends or changes from baseline.

Cite This Study

Goldstein et al. (1990) studied this question.

synapsesocial.com/papers/6a75efeec14fe0c475707869 https://doi.org/10.1148/radiology.174.1.2403679

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January 1, 1990Radiology

Safety assessment of gadopentetate dimeglumine in U.S. clinical trials.

View Full Paper

Ask AI

Bookmark

Authors

HGH A GoldsteinSpecialty Materials (United States)FKFranciska K. KashanianMemorial Sloan Kettering Cancer Center RBR F BlumettiSpecialty Materials (United States)

Discussion

Member takes

Implication

Clinical trial analysis demonstrates high tolerance and minimal adverse effects in adults receiving MRI contrast, suggesting robust safety.

Key Points

To evaluate the safety profile, adverse reaction rates, and laboratory parameter changes associated with intravenous gadopentetate dimeglumine in adult clinical trials.
Analyzed pooled adverse reaction records, laboratory values, and diagnostic assessments from N=1,068 adult patients receiving gadopentetate dimeglumine in United States clinical trials.
Assessed hematologic, blood chemistry, urinary parameters, electrocardiograms, electroencephalograms, neurologic exams, and vital signs before and after administration.
Clinical adverse reactions occurred in 213 of 1,068 patients (19.9%), with the majority described as minor and short-lived.
Hematologic, urinalysis, and chemistry panels showed no drug-related toxicities, apart from a transient, asymptomatic increase in serum iron and bilirubin levels in some patients.
Electrocardiography, electroencephalography, neurologic examinations, and vital signs demonstrated no clinically significant trends or changes from baseline.

Cite This Study

Goldstein et al. (1990) studied this question.

synapsesocial.com/papers/6a75efeec14fe0c475707869 https://doi.org/10.1148/radiology.174.1.2403679

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