TABLE 2.

Differences in clinical characteristics of severe and non‐severe reports.

	Serious cases (n = 867)	Nonserious cases (n = 137)	Statistics	p value
Gender, n (%)
Female	503 (87.48%)	72 (12.52%)	1.395 a	0.237 b
Male	300 (84.75%)	54 (15.25%)	‐	‐
Age, years (Median)	43	51	−1.679 c	0.093 d
Weight, Kg (Median)	71	70	−0.713 c	0.476 d
Types of AEs, n (%)	‐	‐	‐	‐
Dizziness	161	44	13.362 a	< 0.001 b
Tachycardia	121	17	0.239 a	0.625 b
Cardiorespiratory arrest e	57	0	9.549 a	0.002 b
Syncope	52	4	2.128 a	0.145 b
Cardiac arrest e	43	2	3.385 a	0.066 b
Palpitations	41	16	10.671 a	0.001 b
Sinus tachycardia	37	11	3.677 a	0.055 b
Arrhythmia	34	3	1.000 a	0.317 b
Bradycardia	31	4	‐	1.000 f
Myocarditis	27	1	‐	0.161 f
Atrial septal defect e	19	0	‐	0.094 f
Cardiogenic shock e	15	1	‐	0.711 f
Torsade de pointes	13	0	‐	0.235 f
Ventricular extrasystoles e	11	0	‐	0.378 f
Cardiomyopathy	11	2	‐	0.694 f
Dizziness postural	10	1	‐	1.000 f
Ventricular tachycardia	9	0	‐	0.619 f
Cyanosis e	9	2	‐	0.653 f
Cardiovascular disorder	9	0	‐	0.619 f
Ventricular septal defect e	8	0	‐	0.608 f
Ventricular fibrillation e	8	0	‐	0.608 f
Long QT syndrome	7	1	‐	1.000 f
Brugada syndrome e	7	0	‐	0.602 f
Tricuspid valve incompetence e	6	1	‐	1.000 f
Patent ductus arteriosus e	6	0	‐	1.000 f
Congestive cardiomyopathy	6	1	‐	1.000 f
Ventricular arrhythmia	5	0	‐	1.000 f
Tachyarrhythmia	5	0	‐	1.000 f
Supraventricular tachycardia	4	2	‐	0.192 f
Extrasystoles e	4	1	‐	0.521 f
Bundle branch block right e	4	1	‐	0.521 f

Note: The AEs listed above were AEs with significant signal strengths.

p ˂ 0.05 were considered statistically significant.

^a The chi‐square (χ²) statistic of the Pearson chi‐square test.

^b Proportions were compared using Pearson chi‐square test.

^c The Z statistic of the Mann–Whitney U test.

^d Mann–Whitney U test.

^e Emerging findings of quetiapine‐associated cardiac AEs from FAERS database.

^f Fisher's exact test.