Table 4.

Adverse events identified as key features with lower relative reporting rates in the vortioxetine reports compared to the reference reports

MedDRA® preferred terms	Vortioxetine reports, % (n = 8552)	SSRI reports, % (n = 327,478)	Odds ratio	vigiPoint score
Drug withdrawal syndrome	0.11	4.3	0.023	− 1.9
Exposure during pregnancy	0.082	1.6	0.051	− 0.9
Toxicity to various agents	0.14	1.6	0.085	− 0.9
Hyponatraemia	0.53	2.3	0.23	− 0.8
Foetal exposure during pregnancy	0.047	1.3	0.036	− 0.8
Withdrawal syndrome	0.22	1.6	0.14	− 0.7
Tremor	1.5	3.8	0.39	− 0.7
Paraesthesia	0.76	2.4	0.31	− 0.7
Completed suicide	1.0	2.7	0.37	− 0.6
Confusional state	0.74	2.2	0.32	− 0.6
Suicide attempt	0.68	2.1	0.32	− 0.6
Death	0.36	1.5	0.23	− 0.6
Product substitution issue	0.023	0.96	0.024	− 0.6

MedDRA medical dictionary for regulatory affairs, SSRI selective serotonin reuptake inhibitors

^aThese are regular odds ratios and not the shrinkage log-odds ratio described in Sect. 2