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Table 2 Summary of serious adverse events in the included trials

From: Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

Trial Experimental intervention SSRI participants assessed for serious adverse events Placebo participants assessed for serious adverse events
Numbers and types of serious adverse events Proportion of participants with a serious adverse event Numbers and types of serious adverse events Proportion of participants with a serious adverse event
Bose et al., 2008 Escitalopram 1 bowel obstruction, 1 nausea, 1 arrythmia, 1 respiratory arrest, 1 retinal detachment, 1 chest pain 5 out of 96 1 syncope 1 out of 109
Ball et al., 2014 Paroxetine No serious adverse event 0 out of 74 1 unspecified serious adverse event 1 out of 78
Andreoli et al., 2002 Fluoxetine No serious adverse event 0 out of 97 1 suicide 1 out of 76
Kasper et al., 2011 Escitalopram No serious adverse event 0 out of 128 1 hospitalisation due to appendicitis 1 out of 50
Kasper et al. (A), 2005 Escitalopram 1 death (suicide) 1 out of 173 1 death (probably drowned) 1 out of 160
Ravindran et al., 1995 Sertraline 9 unspecified serious adverse events 4 out of 25 3 unspecified serious adverse events 2 out of 13
March et al., 1990 Fluvoxamine 1 hospitalisation due to worsening of depression 1 out of 13 1 suicide attempt 1 out of 12
Rapaport et al., 2009 Paroxetine 2 chestpain, 1 osteoarthritis, 1 ankle fracture, 1 atrial fibrillation, 1 femur fracture,1 coronary artery occlusion, 1 pneumonia, 1 confusional state, 1 depression 10 out of 267 1 neprholithiasis, 1 aortic aneurism 2 out of 127
Higuchi et al., 2011 Paroxetine 1 suicide and 8 unspecified serious adverse events 9 out of 213 1 unspecified serious adverse event 1 out of 139
Schneider et al., 2003 Sertraline 17 unspecified serious adverse events 17 out of 284 11 unspecified serious adverse events 11 out of 311
Sheehan et al., 2009 Fluoxetine 1 suicidal ideation/suicidality, 1 worsening of depression, 2 suicide attempts, 1 anxiety/agitation/racing thoughts, 1 syncope, 1 ankle fracture, 1 viral gastro enteritis 8 out of 76 2 suicidal ideation/suicidality, 2 worsening of depression, 1 nose bleed, 1 allergic reaction 6 out of 67
Nemroff et al., 2005 Fluxetine 1 unspecified serious adverese event 1 out of 86 1 unspecified serious adverse event 1 out of 78
Fabre et al., 1996 Fluvoxamine 1 hospitalisation (non-cardiac chest pain) 1 out of 22 1 hospitalisation, 1 ruptured ectopic pregnancy, 1 hernia repair 2 out of 19
Feighner et al., 1999 Citalopram 3 suicide attempts, 1 miscarriage, 1 intestinal flu symptoms, 1 chest pain, 1 severe thinking abnormality, 1 allergic reaction 8 out of 349 No serious adverse event 0 out of 86
SCT-MD 01 (B), 2002 Escitalopram 1 anaphylaxis, 1 suicide attempt 2 out of 94 1 gallbladder stones 1 out of 46
SCT-MD 01 (C), 2002 Citalopram 1 coma, 1 intestinal fistula 2 out of 93 1 non-accidental overdose 1 out of 45
SCT-MD 02 (A), 2002 Escitalopram 1 suicidal tendency, suicide attempt; 1 non-accidental overdose, suidal attempt, tachycardia 2 out of 96 No serious adverse event 0 out of 53
SCT-MD 02 (B), 2002 Citalopram 1 cholestasis intrahepatic, dehydration 1 out of 99 No serious adverse event 0 out of 52
Pettinati et al., 2010 Sertraline 15 unspecified serious adverse events 15 out of 40 11 unspecified serious adverse events 11 out of 39
Dube et al., 2010 Escitalopram 1 suicide attempt, 1 gastro enteritis/malaria 2 out of 54 1 near drowning, 1 gastro enteritis 2 out of 122
Learned et al., 2012 Paroxetine 1 intentional over dose, 1 depression, 1 unspecified event 3 out of 166 2 unspecified serious adverese events 2 out of 156
Ratti et al., 2011 Paroxetine 1 hemorrhoidal hemorrhage 1 out of 109 1 rash 1 out of 123
Wang et al., 2014 Escitalopram 3 unspecified serious adverese event 3 out of 114 1 unspecified serious adverese event 1 out of 115
Detke et al., 2004 Paroxetine 1 unspecified serious adverese event 1 out of 85 No serious adverse event 0 out of 93
Mancino et al., 2014 Sertraline 1 hospitalization 1 out of 23 No serious adverse event 0 out of 27
DeRubeis et al., 2005 Paroxetine 1 suicide 1 out of 120 No serious adverse event 0 out of 60
29060-785 (A), 2005 Paroxetine CR 25 mg 3 abnormal laboratory vaue, 1 emotional lability 4 out of 98 1 abnormal laboratory value, 1 gastrointestinal disorder 2 out of 26
29060-785 (B), 2005 Paroxetine CR 12.5 mg 1 abnormal laboratory value 1 out of 94 1 abnormal laboratory value, 1 myocardial infarction 2 out of 26
29060-785 (C), 2005 Citalopram 20 mg 5 abnormal laboratory value, 1 syncope 6 out of 105 1 abnormal laboratory value, 1 suicide 2 out of 25
29060-785 (D), 2005 Citalopram 40 mg 1 abnormal laboratory vaue, 1 emotional lability 2 out of 97 1 abnormal laboratory value 1 out of 25
SCT-MD 27 (A), 2005 Escitalopram 1 depression, 1 abnormal mental status, 1 malignant neoplasm 3 out of 131 1 labyrinthitis 1 out of 66
SCT-MD 27 (B), 2005 Sertraline 1 appendicitis 1 out of 135 No serious adverse event 0 out of 66
SCT-MD 35, 2007 Escitalopram 1 abnormal hepatic function 1 out of 131 1 breast cancer, 1 depression, 1 suicidal ideation, 1 suicide 4 out of 130
SCT-MD 26, 2005 Escitalopram 1 inflicted injury 1 out of 143 No serious adverse event 0 out of 151
MY-1043/BRL-029060/115 (A), 2005 Paroxetine 1 hypertension, 1 diabetes and hypothyroidism, 1 Fibrocystic disease, 1 Ovarian cysts, 1 peptic ulcer hemorrhage, 1 spinal surgery, 1 hypomanic episode with suicidal tendency, 2 Suicidal ideation, 1 alcoholism, 1 neoplasm 11 out of 272 1 suicidal ideation, 1 back pain, 1 trauma 3 out of 57
MY-1043/BRL-029060/115 (B) Fluoxetine 1 suicidal ideation, 1 neoplasm, 2 acute pyelonephritis, 1 thrombophlebitis, 1 ectopic pregnancy, 1 polycystic granuloma, 2 basal cell carcinomas, 1 myxoid mitral valve 9 out of 278 (10 SAE in 9 participants) 1 viral meningitis, 1 infection, 1 myocardial infarction, 1 mole removal 3 out of 56 (4 SAE in 3 participants)
MY-1045/BRL-029060/1, (A), 2005 Paroxetine 2 depression (worsening), 2 emotional lability, 1 neoplasm, 1 insomnia, 1 nervousness, 1 carcinoma, 1 epistaxis, 1 gastro intestinal disorder, 1 prostate disorder 9 out of 357 (11 SAE in 9 participants) 1 depression (worsening), 1 rectal disorder 2 out of 70
MY-1045/BRL-029060/1, 2005 Fluoxetine 1 depression (worsening), 2 emotional lability, 1 neo plasm, 1 coronary artery disease, 1 thrombo phlebitis, 1 hypoglycemia 7 out of 351 2 depression (worsening), 1 flu syndrome disorder 2 out of 70
29060/448 (A), 2005 Paroxetine IR 1 myocardial infarction, 1 emotional lability 2 out of 104 1 uterine fibroids enlarged, 1 gall bladder disorder 2 out of 50
29060/448 (B), 2005 Paroxetine CR 3 emotional lability, 1 hepatocellular jaundice, 1 manic reaction 6 out of 102 1 dehydration, 1 accidental overdose 2 out of 51
29060/449 (A), 2005 Paroxetine IR 1 emotional lability, 1 abortion, 2 unintended pregnancy 3 out of 112 (4 SAE in 3 participants) No serious adverse event 0 out of 55
29060/449 (B), 2005 Paroxetine CR 1 abdominal pain, 1 pancreatitis, 1 accidental over dose, 1 unintended pregnancy 2 out of 108 (4 SAE in 2 participants) No serious adverse event 0 out of 55
PAR 29060.07.001, 2008 Paroxetine 1 acure depression, 1 acute alcohol intoxication and suicide ideation 2 out of 13 No serious adverse event 0 out of 12
Nyth et al., 1992 Citalopram 1 cerebral hemorrhage and death 1 out of 98 1 death 1 out of 51
Perahia et al., 2006 Paroxetine 1 back pain, 1 breast neoplasm 2 out of 97 No serious adverse events 0 out of 99
Mendels et al., 1999 Citalopram 1 prostatic hyper trophy, 1 bronchitis 2 out of 89 1 suicide 1 out of 91
NCT00668525 (A), 2010 Escitalopram 1 chest pain, 1 pharyngitis 1 multiple sclerosis 3 out of 319 1 asthma, 1 haemothorax 2 out of 108
NCT00668525 (B), 2010 Escitalopram 1 chest pain, 1 appendicitis, 2 anxiety, 1 suicidal ideation, 1 suicide attempt, 1 peripheral vasuclar disorder 7 out of 318 1 injury, 1 suicidal ideation 2 out of 107
Nierenberg et al., 2007 Escitalopram 1 death and 3 unspecified serious adverse events 4 out of 274 2 unspecified serious adverse events 2 out of 137
WELL AK130926, 2007 Escitalopram 1 agitation 1 out of 144 No serious adverse event 0 out of 132
WELL AK130927, 2007 Escitalopram 2 suicidal ideation, 1 hepatic function abnormal 3 out of 138 1 suicidal ideation, 1 sudden caridac death 2 out of 141
NCT01473381, 2014 Escitalopram 1 haemorrhagic anaemia, 1 diverticulitis, 1 ilium fracture, 1 road traffic accident, 1 traumatic renal injury, 1 wrist fracture, 1 abortion missed, 1 suicidal ideation, 1 hospitalisaation 6 out of 280 (9 SAE in 6 participants) 1 angina pectoris, 1 gastric disorder, 1 pneumonia, 1 neck abscess, 1 oral abscess, 1 abnormal electrocardiogram ST segment, 1 back pain, 1 suicidal ideation, 1 obstructive airways disorder 3 out of 281 (9 SAE in 3 participants)
Adamson et al., 2015 Citalopram 1 suicidal ideation, severe abdominal cramps 2 out of 73 No serious adverse event 0 out of 65
CIT-MD-03, 2005 Citalopram 2 congestive heart failure, 1 cerebro vascular accident, 1 hyponatremia 4 out of 84 1 cerebro vascular accident, 1 cellulitis 2 out of 90
29060/810 (A), 2005 Paroxetine CR 12.5 mg 2 abnormal laboratory value, 1 carcinoma of lung 3 out of 153 1 cerebro vascular disorder, 1 depression 1 out of 73 (2 SAE in 1 participants)
29060/810 (B), 2005 Paroxetine CR 25 mg 1 abnormal laboratory value, 1 gall bladder disorder, 1 anxiety, 1 emotional lability, 4 out of 148 1 pleura disorder, 1 sinusitis, 1 bronchitis 2 out of 73 (3 SAE in 2 participants)
  1. SAE Serious adverse event