Table S1.
PV endpoint definition
| PV endpoint/SMQ | MedDRA PT |
|---|---|
| Abdominal pain | Abdominal pain; abdominal pain lower; abdominal pain upper; abdominal rebound tenderness; abdominal tenderness; epigastric discomfort; gastrointestinal pain |
| Aneurysm | Aneurysm; aneurysm arteriovenous; aneurysm ruptured; aortic aneurysm; aortic aneurysm rupture; aortic aneurysm syphilitic; aortic dissection; aortic dissection rupture; aortic intramural hematoma; aortic stent insertion; artery dissection; cardiac aneurysm; carotid aneurysm rupture; cerebral aneurysm ruptured syphilitic; Charcot–Bouchard microaneurysms; coronary artery aneurysm; coronary artery dissection; dissecting coronary artery aneurysm; femoral artery aneurysm; femoral artery dissection; hemorrhage coronary artery; hepatic artery aneurysm; infective aneurysm; intracranial aneurysm; mycotic aneurysm; peripheral artery aneurysm; peripheral artery dissection; pulmonary artery aneurysm; renal aneurysm; renal artery dissection; retinal aneurysm; ruptured cerebral aneurysm; splenic artery aneurysm; subclavian artery aneurysm; superior vena cava dilatation; venous aneurysm |
| Anxiety symptoms/fears | Acrophobia; activation syndrome; acute stress disorder; agitation; agitation neonatal; agoraphobia; animal phobia; anticipatory anxiety; anxiety; anxiety disorder; anxiety disorder due to a general medical condition; arachnophobia; autophobia; Burnout syndrome; claustrophobia; compulsions; compulsive hand washing; dysmorphophobia; emetophobia; fear; fear of animals; fear of closed spaces; fear of crowded places; fear of death; fear of disease; fear of eating; fear of falling; fear of needles; fear of open spaces; fear of pregnancy; fear of weight gain; generalized anxiety disorder; haphephobia; hydrophobia; limited symptom panic attack; nervousness; neurosis; noctiphobia; nocturnal fear; nosophobia; obsessive thoughts; obsessive-compulsive disorder; ochlophobia; osmophobia; pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection; panic attack; panic disorder; panic disorder with agoraphobia; panic disorder without agoraphobia; panic reaction; paruresis; performance fear; phagophobia; pharmacophobia; phobia; phobia of driving; phobia of exams; phobia of flying; phobic avoidance; phonophobia; photaugiaphobia; post-traumatic stress disorder; postpartum neurosis; postpartum stress disorder; social fear; social phobia; stress; tension; thanatophobia |
| Cardiac arrest | Atrioventricular dissociation; cardiac arrest; cardiac death; cardiac massage; cardiorespiratory arrest; cardiogenic shock; pulseless electrical activity; resuscitation |
| Cardiac failure (SMQ cardiac failure [narrow]) | Acute left ventricular failure; acute pulmonary edema; acute right ventricular failure; cardiac asthma; cardiac failure; cardiac failure acute; cardiac failure chronic; cardiac failure congestive; cardiac failure high output; cardiogenic shock; cardiopulmonary failure; cardiorenal syndrome; chronic left ventricular failure; chronic right ventricular failure; cor pulmonale; cor pulmonale acute; cor pulmonale chronic; ejection fraction decreased; hepatic congestion; hepatojugular reflux; left ventricular failure; low cardiac output syndrome; neonatal cardiac failure; pulmonary edema; pulmonary edema neonatal; right ventricular failure; ventricular failure |
| Cognitive impairment | Cognitive disorder |
| Confusion | Confusion postoperative; confusional state; disorientation |
| Constipation | Colonic pseudo-obstruction; constipation; feces hard; infrequent bowel movements; postprocedural constipation |
| COPD exacerbation | Chronic obstructive pulmonary disease; infective exacerbation of chronic obstructive airways disease; obstructive airways disorder |
| Dehydration | Dehydration |
| Depression and self-injury (SMQ depression and self-injury (excluding suicide and self-injury) (narrow) | Activation syndrome; adjustment disorder with depressed mood; adjustment disorder with mixed anxiety and depressed mood; agitated depression; anhedonia; antidepressant therapy; childhood depression; decreased interest; depressed mood; depression; depression postoperative; depressive symptom; dysphoria; dysthymic disorder; electroconvulsive therapy; feeling guilty; feeling of despair; feelings of worthlessness; major depression; menopausal depression; postpartum depression |
| Dizziness | Dizziness; dizziness exertional; dizziness postural; vertigo; vertigo positional |
| Dry mouth | Aptyalism; dry mouth; dry throat; lip dry |
| Dyspepsia (including reflux) | Abdominal discomfort; dyspepsia; epigastric discomfort; esophageal pain; esophagitis; gastritis; gastroesophageal reflux disease; reflux gastritis; reflux laryngitis |
| Dysphagia | Dysphagia; esophageal hypomotility; malignant dysphagia |
| Dysuria | Dysuria; strangury |
| Gastroesophageal reflux disease | Dyspepsia; esophageal pain; esophagitis; reflux gastritis; gastroesophageal reflux; disease; reflux laryngitis |
| Gastrointestinal obstruction (SMQ gastrointestinal perforation, ulceration, hemorrhage, or obstruction) | Anal stenosis; anastomotic stenosis; anastomotic ulcer, obstructive; anorectal stenosis; barium impaction; colonic obstruction; colonic stenosis; distal ileal obstruction syndrome; distal intestinal obstruction syndrome; duodenal obstruction; duodenal scarring; duodenal stenosis; duodenal ulcer perforation, obstructive; duodenal ulcer, obstructive; esophageal obstruction; esophageal stenosis; fibrosing colonopathy; gastric stenosis; gastric ulcer hemorrhage, obstructive; gastric ulcer perforation, obstructive; gastric ulcer, obstructive; gastrointestinal anastomotic leak; gastrointestinal hypomotility; gastrointestinal motility disorder; gastrointestinal obstruction; gastrointestinal stenosis; ileal stenosis; impaired gastric emptying; intestinal obstruction; intestinal stenosis; jejuna tenosis; large intestinal obstruction; large intestinal obstruction reduction; large intestinal stricture; necrotizing colitis; necrotizing gastritis; necrotizing esophagitis; neonatal intestinal obstruction; obstruction gastric; peptic ulcer perforation, obstructive; peptic ulcer, obstructive; prepyloric stenosis; rectal obstruction; rectal stenosis; small intestinal bacterial overgrowth; small intestinal obstruction; small intestinal stenosis |
| Glaucoma (SMQ glaucoma) (narrow) | Angle closure glaucoma; borderline glaucoma; developmental glaucoma; diabetic glaucoma; fundoscopy abnormal; glaucoma; glaucoma drug therapy; glaucoma surgery; glaucoma traumatic; glaucomatocyclitic crises; glaucomatous optic disc atrophy; gonioscopy abnormal; halo vision; intraocular pressure; fluctuation; intraocular pressure increased; intraocular pressure test abnormal; iridotomy; loss of visual contrast sensitivity; normal tension glaucoma; ocular hypertension; open angle glaucoma; ophthalmic fluid drainage; optic discs blurred; optic nerve cup/disc ratio increased; optic nerve cupping; phacolytic glaucoma; phacotrabeculectomy; pigmentary glaucoma; pupillary light reflex tests abnormal; slit-lamp tests abnormal; trabeculectomy; trabeculoplasty; visual field tests abnormal |
| Headache | Basilar migraine; chronic paroxysmal hemicrania; cluster headache; complicated migraine; drug withdrawal headache; headache; migraine; migraine with aura; migraine without aura; ophthalmoplegic migraine; post-traumatic headache; postictal headache; retinal migraine; SUNCT syndrome; sinus headache; status migrainosus; temporomandibular joint syndrome; tension headache; typical aura without headache |
| Hyperglycemia/new-onset diabetes mellitus (SMQ Hyperglycemia/new-onset diabetes mellitus) (narrow) | Blood 1,5-anhydroglucitol decreased; blood glucose increased; diabetes complicating pregnancy; diabetes mellitus; diabetes mellitus inadequate control; diabetes with hyperosmolarity; diabetic coma; diabetic hyperglycemic coma; diabetic hyperosmolar coma; diabetic ketoacidosis; diabetic ketoacidotic hyperglycemic coma; fructosamine increased; gestational diabetes; glucose tolerance impaired; glucose tolerance impaired in pregnancy; glucose urine present; glycosuria; glycosuria during pregnancy; glycosylated hemoglobin increased; hyperglycemia; hyperglycemic hyperosmolar nonketotic syndrome; impaired fasting glucose; insulin resistance; insulin resistance syndrome; insulin-resistant diabetes; insulin-requiring Type 2 diabetes mellitus; ketoacidosis; ketonuria; ketosis; latent autoimmune diabetes in adults; metabolic syndrome; neonatal diabetes mellitus; pancreatogenous diabetes; Type 1 diabetes mellitus; Type 2 diabetes mellitus; urine ketone body present |
| Hypertension | Accelerated hypertension; blood pressure ambulatory increased; blood pressure diastolic increased; blood pressure inadequately controlled; blood pressure increased; blood pressure orthostatic increased; blood pressure systolic increased; diastolic hypertension; endocrine hypertension; essential hypertension; hypertension; hypertensive angiopathy; hypertensive cardiomegaly; hypertensive cardiomyopathy; hypertensive crisis; hypertensive emergency; hypertensive encephalopathy; hypertensive heart disease; hypertensive nephropathy; labile hypertension; Liddle’s syndrome; malignant hypertension; malignant hypertensive heart disease; malignant renal hypertension; mean arterial pressure increased; neurogenic hypertension; orthostatic hypertension; paradoxical pressor response; procedural hypertension; renal hypertension; renovascular hypertension; secondary hypertension; systolic hypertension |
| Insomnia | Initial insomnia; insomnia; middle insomnia; poor quality sleep; sleep disorder; sleep phase rhythm disturbance; somnambulism |
| Ischemic heart disease (SMQ ischemic heart disease sub-SMQ other ischemic heart disease) (broad) | Angina pectoris; angina unstable; arteriogram coronary abnormal; arteriosclerosis coronary artery; arteriospasm coronary; cardiac stress test abnormal; computerized tomogram; coronary artery abnormal; coronary angioplasty; coronary arterial stent insertion; coronary artery bypass; coronary artery disease; coronary artery dissection; coronary artery insufficiency; coronary artery restenosis; coronary artery stenosis; coronary endarterectomy; coronary no-reflow phenomenon; coronary ostial stenosis; coronary revascularization; dissecting coronary artery aneurysm; electrocardiogram signs of myocardial; electrocardiogram ST segment depression; electrocardiogram ST–T segment abnormal; electrocardiogram ST–T segment depression; electrocardiogram T-wave abnormal; electrocardiogram T-wave inversion; exercise electrocardiogram abnormal; exercise test abnormal; external counterpulsation; hemorrhage coronary artery; in-stent coronary artery restenosis; ischemic cardiomyopathy; microvascular angina; myocardial ischemia; other ischemic heart disease (broad) ischemia; percutaneous coronary intervention; prinzmetal angina; stress cardiomyopathy; stress echocardiogram abnormal; subclavian coronary steal; syndrome; subendocardial ischemia |
| MI (SMQ ischemic heart disease sub-SMQ myocardial infarction) (broad) | Acute coronary syndrome; acute myocardial infarction; blood creatine phosphokinase; MB abnormal; blood creatine phosphokinase; MB increased; blood creatine phosphokinase abnormal; blood creatine phosphokinase increased; cardiac enzymes increased; coronary artery embolism; coronary artery occlusion; coronary artery reocclusion; coronary artery thrombosis; coronary bypass thrombosis; electrocardiogram electrically inactive area; electrocardiogram Q-wave abnormal; electrocardiogram ST segment abnormal; electrocardiogram ST segment elevation; electrocardiogram ST–T segment elevation; infarction; Kounis syndrome; myocardial infarction; myocardial reperfusion injury; myocardial stunning; papillary muscle infarction; postprocedural myocardial infarction; postinfarction angina; scan myocardial perfusion abnormal; silent myocardial infarction; troponin I increased; troponin T increased; troponin increased; vascular graft occlusion |
| Palpitations | Extrasystoles; palpitations; supraventricular extrasystoles; ventricular extrasystoles |
| Pneumonia | Atypical mycobacterial pneumonia; bronchopneumonia; congenital pneumonia; embolic pneumonia; Enterobacter pneumonia; lobar pneumonia; miliary pneumonia; neonatal pneumonia; pneumonia; pneumonia adenoviral; pneumonia anthrax; pneumonia bacterial; pneumonia blastomyces; pneumonia Bordetella; pneumonia Chlamydial; pneumonia Cryptococcal; pneumonia Cytomegaloviral; pneumonia Escherichia; pneumonia fungal; pneumonia hemophilus; pneumonia helminthic; pneumonia herpes viral; pneumonia influenzal; pneumonia Klebsiella; pneumonia Legionella; pneumonia measles; pneumonia Moraxella; pneumonia mycoplasmal; pneumonia necrotizing; pneumonia parainfluenzae viral; pneumonia pneumococcal; pneumonia primary atypical; pneumonia respiratory syncytial viral; pneumonia Salmonella; pneumonia Staphylococcal; pneumonia Streptococcal; pneumonia toxoplasmal; pneumonia Tularemia; pneumonia viral; post procedural pneumonia |
| Renal failure | Acute prerenal failure; anuria; cardiorenal syndrome; diabetic end-stage renal disease; hepatorenal failure; postoperative renal failure; renal failure; renal failure acute; renal failure chronic |
| Respiratory failure | Acute respiratory failure; cardiopulmonary failure; chronic respiratory failure; hypoxia; respiratory acidosis; respiratory failure; respiratory paralysis |
| Restlessness | Agitation; psychomotor hyperactivity; restlessness |
| Sleep disturbance | Abnormal dreams; insomnia; nightmare; poor quality sleep; sedation; sleep disorder; sleep phase rhythm disturbance; sleep talking; somnambulism; somnolence |
| Stomatitis | Aphthous stomatitis; mouth ulceration; oral mucosal eruption; oropharyngeal blistering; stomatitis; stomatitis hemorrhagic; stomatitis necrotizing |
| Stroke | Amaurosis fugax; basal ganglia hemorrhage; basilar artery occlusion; basilar artery thrombosis; brachiocephalic artery occlusion; brain stem hemorrhage; brain stem infarction; brain stem ischemia; brain stem stroke; brain stem thrombosis; carotid aneurysm rupture; carotid arterial embolus; carotid artery occlusion; carotid artery thrombosis; central nervous system hemorrhage; cerebellar artery occlusion; cerebellar artery thrombosis; cerebellar embolism; cerebellar hematoma; cerebellar hemorrhage; cerebellar infarction; cerebellar ischemia; cerebral arteriovenous malformation hemorrhagic; cerebral artery embolism; cerebral artery occlusion; cerebral artery thrombosis; cerebral hematoma; cerebral hemorrhage; cerebral hemorrhage fetal; cerebral hemorrhage neonatal; cerebral infarction; cerebral infarction fetal; cerebral ischemia; cerebral thrombosis; cerebrovascular accident; embolic cerebral infarction; embolic stroke; hemorrhage intracranial; hemorrhagic cerebral infarction; hemorrhagic stroke; hemorrhagic transformation stroke; intracranial hematoma; intracranial tumor hemorrhage; intraoperative cerebral artery occlusion; intraventricular hemorrhage; intraventricular hemorrhage neonatal; ischemic cerebral infarction; ischemic stroke; lacunar infarction; lateral medullary syndrome; pituitary hemorrhage; pituitary infarction; postprocedural stroke; precerebral artery occlusion; putamen hemorrhage; reversible ischemic neurological deficit; ruptured cerebral aneurysm; stroke in evolution; subarachnoid hemorrhage; subarachnoid hemorrhage neonatal; subdural hemorrhage neonatal; thalamic infarction; thalamus hemorrhage; thrombotic cerebral infarction; thrombotic stroke; transient ischemic attack; vertebral artery dissection; vertebral artery occlusion; vertebral artery thrombosis |
| Supraventricular tachycardia | Atrial tachycardia; postural orthostatic tachycardia syndrome; sinus tachycardia; supraventricular tachycardia; tachycardia paroxysmal |
| Syncope | Loss of consciousness; presyncope; syncope |
| Tachycardia | Heart rate increased; sinus tachycardia; tachycardia |
| Urinary retention | Bladder neck obstruction; residual urine volume increased; urinary hesitation; urinary retention; urinary retention postoperative; urinary tract obstruction; urine flow decreased |
| Urinary tract infection | Adenoviral hemorrhagic; cystitis; asymptomatic bacteriuria; bacterial pyelonephritis; bacteriuria; bladder candidiasis; cystitis; cystitis Escherichia; cystitis glandularis; cystitis gonococcal; cystitis hemorrhagic; cystitis interstitial; cystitis Klebsiella; cystitis noninfective; cystitis pseudomonal; cystitis radiation; cystitis ulcerative; cytomegalovirus urinary tract infection; emphysematous cystitis; eosinophilic cystitis; Escherichia urinary tract infection; fungal cystitis; genitourinary tract infection; kidney infection; perinephric abscess; pyelocystitis; pyelonephritis; pyelonephritis acute; pyelonephritis chronic; pyelonephritis mycoplasmal; pyonephrosis; renal abscess; renal cyst infection; schistosomiasis bladder; Streptococcal urinary tract infection; trigonitis; tuberculosis bladder; ureter abscess; ureteritis; urethral abscess; urethral carbuncle; urethral stricture post infection; urethritis; urinary bladder abscess; urinary tract abscess; urinary tract infection; urinary tract infection bacterial; urinary tract infection enterococcal; urinary tract infection fungal; urinary tract infection neonatal; urinary tract infection pseudomonal; urinary tract infection staphylococcal; urosepsis; viral hemorrhagic cystitis |
| Ventricular tachycardia/fibrillation | Ventricular fibrillation; ventricular tachycardia |
| Vision blurred | Accommodation disorder; altered visual depth perception; diplopia; erythropsia; glare; halo vision; hypermetropia; loss of visual contrast sensitivity; malignant myopia; myopia; night blindness; oscillopsia; phosphenes; photopsia; presbyopia; refraction disorder; tunnel vision |
Abbreviations: MB, creatine kinase-MB; MedDRA, Medical Dictionary for Regulatory Activities; MI, myocardial infarction; PT, preferred term; PV, pharmacovigilance; SMQ, standardized MedDRA queries.