Table 5.

Comparison of events in patients with depression in the TOBYO database and JADER database.

Medical terms observed in the TOBYO database				Medical terms observed in the JADER database
Rank	Event description in the TOBYO database	MedDRA Preferred Terms in the TOBYO database	Number of events	Rank MedDRA Preferred Terms in the JADER database	Number of events
1	Adverse reactionc	Adverse reaction	9977	1	Inappropriate antidiuretic hormone secretion	247
2	Depression	Depression	6218	2	Serotonin syndrome	226
3a	Anxiety	Anxiety	5695	3	Suicide attempt	213
4	Headache	Headache	2977	4	Seizure	153
5	Pain	Pain	2016	5	Completed suicide	152
6	Withdrawal symptom	Withdrawal syndrome	1848	6	Hyponatraemia	143
7	Stress	Stress	1194	7a	Mania	121
8	Malaise	Malaise	1162	8	Neuroleptic malignant syndrome	108
9a	Feeling queasy	Nausea	1140	9a	Dizziness	103
10	Constipation	Constipation	897	10a	Nausea	101
11	Psychosisc	Mental disorder	777	11	Aggression	100
12a	Dizzy	Dizziness	762	12	Suicidal ideation	96
13	Paroxysmal attackc	Seizure-like phenomena	691	13	Hepatic function abnormal	93
14	Emotional instabilityc	Affect lability	685	14a	Tremor	92
15	Abnormality	NAb	641	15	Altered state of consciousness	90
16	Sufferingc	Sense of oppression	637	16	Activation syndromed	86
17	Feeling downc	Depressed mood	619	17	Irritability	85
18	Sleep disorder	Sleep disorder	601	18	Loss of consciousness	78
19	Schizophrenia	Schizophrenia	479	19a	Anxiety	75
20	Allergy	Hypersensitivity	474	20	Hallucination	74
21a	Mania	Mania	472	21	Somnolence	69
22	Migraine	Migraine	445	22	Delirium	68
23	Pollinosis	Seasonal allergy	427	23	Liver disorder	61
24	Hypersomnia	Hypersomnia	418	24	Urinary retention	60
25	Bipolar disorder	Bipolar disorder	376	25	Overdose	58
26	Diarrhea	Diarrhea	368	26a	Intentional self-injury	57
27a	Trembling	Tremor	326	27	Electrocardiogram QT prolonged	56
28	Panic disorder	Panic disorder	314	28	Drug withdrawal syndrome neonatal	53
29	Asthma	Asthma	294	29	Insomnia	50
30	Weight increased	Weight increased	284		Intentional overdose	50
31	Diabetes mellitus	Diabetes mellitus	281
32	Ache stomach	Abdominal pain upper	277
33	Psychiatric disorderc	Mental disorder	266
34	Vomiting	Vomiting	240
35	Abdominal pain	Abdominal pain	237
36	Slight fever	Pyrexia	231
37	Influenza	Influenza	228
38	Physical deconditioning	Asthenia	226
39	Myalgia	Myalgia	225
40	Dependence	Dependence	210
41	Inflammation	Inflammation	206
42	Panic attack	Panic attack	197
43a	Self-injury	Intentional self-injury	194
44	Hypertension	Hypertension	179
45	Severe pain	Pain	152

^aEvents appearing in both databases (the TOBYO database and JADER database).

^bNA (not applicable) in columns for MedDRA PTs (preferred terms) means there was no corresponding term in MedDRA.

^cCoding discrepancies occurred between the 2 reviewers (the different suggestions from the reviewers are shown in parentheses): Adverse reaction (adverse reaction or adverse drug reaction), Psychosis (mental disorder or psychotic disorder), Paroxysmal attack (seizure-like phenomena or seizure), Emotional instability (affect lability or feeling abnormal), Suffering (sense of oppression or emotional distress), Feeling down (depressed mood or emotional distress), and Psychiatric disorder (mental disorder or psychotic disorder).

^dActivation syndrome is a generic term used for central nervous system stimulation symptoms that are potential adverse effects caused by selective serotonin reuptake inhibitors.