Keywords:
Contrast agents, Abdomen, Kidney, CT, Digital radiography, Fluoroscopy, Contrast agent-intravenous, Safety, Drugs / Reactions, Toxicity, Quality assurance
Authors:
A. Gottschalk, B. Kress; Frankfurt/DE
DOI:
10.1594/ecr2018/C-1310
Methods and materials
A two-page report form was used to record the data.
The report form included 9 sections: patient information (age,
sex,
height,
weight),
known risk factors (bronchial asthma,
CNS disorder,
coronary heart disease,
diabetes mellitus,
diuretics,
heart failure,
history of a reaction to a contrast agent,
hypertension,
known allergies,
pheochromocytoma,
poor general condition,
severe liver dysfunction,
sickle cell anemia,
thyroid dysfunction,
water balance/electrolyte metabolism disturbed),
impaired renal function,
premedication,
type of examination,
injection of contrast agent,
imaging quality,
diagnostic value and safety.
The data was descriptively analysed.
Each variable was analysed for relative and absolute frequencies.
Continuous variables were classified in advance.
The following statistical parameters were also calculated for continuous variables: mean,
standard deviation (SD),
number of valid cases,
minimum,
maximum,
5th percentile,
50th percentile (median),
95th percentile.
The analysis of adverse events was performed according to the relevant Medical Dictionary of Regulatory Activities (MedDRA) System Organ Class (SOC) 16.1.
Seriousness,
causal relationship and outcome of adverse events were analysed and percentages are presented with reference to the total number of patients (total results) and to the number of patients with at least one adverse event (adjusted results).
Medically important adverse events were classified as serious in line with the relevant International Conference on Harmonization (ICH)/Good Clinical Practice (GCP)- guideline.