The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study
Table 2
Characteristics and symptoms (by SOC and PT) of adverse reactions in the whole study population.
Adverse reactions
N = 1376
No. of subjects
No. of events
Incidence rate (%)
95% CI (lower, upper)
Type of adverse reaction
Immediate
8
9
0.58
(0.002, 0.010)
Delayed
2
5
0.15
(−0.001, 0.004)
Severity
Mild
10
14
0.73
(0.003, 0.012)
Moderate
0
0
0
—
Severe
0
0
0
—
Causality
Certain
1
2
0.07
(−0.001, 0.002)
Likely
0
0
0
—
Possible
9
12
0.65
(0.002, 0.011)
Unlikely
0
0
0
—
Unassessable
0
0
0
—
Body region of MR exam
Immune system
1
1
0.07
(−0.001, 0.002)
Musculoskeletal system
1
3
0.07
(−0.001, 0.002)
Nervous system
4
5
0.29
(0.000, 0.006)
Sensory system
1
2
0.07
(−0.001, 0.002)
Vascular system
1
1
0.07
(−0.001, 0.002)
Whole body
2
2
0.15
(−0.001, 0.004)
Total
10
14
0.73
(0.003, 0.012)
Adverse reactions by SOC/PT
No. of subjects
No. of events
Incidence rate (%)
95% CI (lower, upper)
Gastrointestinal disorders
1
1
0.07
(−0.001, 0.002)
Nausea
1
1
0.07
(−0.001, 0.002)
General disorders and administration site conditions
2
2
0.15
(−0.001, 0.004)
Chills
1
1
0.07
(−0.001, 0.002)
Oedema
1
1
0.07
(−0.001, 0.002)
Investigations
4
4
0.29
(0.000, 0.006)
Oxygen saturation decreased
4
4
0.29
(0.000, 0.006)
Skin and subcutaneous
4
7
0.29
(0.000, 0.006)
Tissue disorders
Pruritus
4
4
0.29
(0.000, 0.006)
Urticaria
3
3
0.22
(−0.0003, 0.005)
Total
10
14
0.73
(0.003, 0.012)
PT: preferred term; SOC: system organ class, MedDRA (Ver. 20.1). All cases registered in MR examinations under sedation.
