SIDERデータの集計

臨床試験ではプラセボが投与された被験者にも当然のように有害事象が起きます。多くはプラセボの「薬効」ではなく、偶発症だろうと思います。基礎疾患の症状であったり、併用薬剤の副作用であったり、さまざまな偶発症で有害事象が起きます。SIDERデータベースは、添付文書の副作用情報をまとめた物です。（それ以外の情報源も含むようですが）　最新のversion 4.1には1400剤を超える医薬品の「副作用」情報が14万件弱ほど登録されています。その中には、当該医薬品の試験に際してプラセボが投与された被験者のデータを添付文書に掲載しているものがあり、今回はこの中で添付文書由来のデータのプラセボが投与された被験者のデータを集計しました。言うならば、「プラセボ」の有害事象データです。さまざまな疾患に対する様々な医薬品の試験でのプラセボのデータですので、かなり高い頻度で有害事象が発現している場合もあります。

Frequency of Adverse Event in Placebo

Adverse Event	Frequency	LowerLimit	UpperLimit
Abdominal bloating	0.08	0.014	0.08
Abdominal discomfort	0.215	0	0.215
Abdominal distension	0.1	0	0.1
Abdominal distress	0.215	0.215	0.215
Abdominal pain	0.44	0	0.440252
Abdominal pain upper	0.17	0	0.17
Abdominal tenderness	0	0	0
Abnormal behaviour	0.09	0.01	0.09
Abnormal dreams	0.17	0	0.17
Abnormal ejaculation	0.181	0	0.180894
Abnormal faeces	0.04	0.04	0.04
Abnormal involuntary movements	0.21	0.21	0.21
Abnormal labour	0.005	0.005	0.005
Abnormal sleep-related event	0	0	0
Abnormal vision	0.06	0	0.06
Abrasion NOS	0	0	0
Abscess	0.059	0	0.059
Abscess periodontal	0.0977	0.0976744	0.0976744
Accident	0.11	0.11	0.11
Accident at home	0.019	0.019	0.019
Accidental injury	0.2	0	0.2
Accidental overdose	0	0	0
Accommodation disorder	0.0112	0	0.0112
Ache	0.032	0	0.032
Acid indigestion	0.0326	0.0325581	0.0325581
Acidosis	0.02	0	0.02
Acne	0.19	0	0.19
Action tremor	0.029	0.01	0.029
Acute appendicitis	0.006	0.006	0.006
Acute bronchitis	0.01	0.01	0.01
Acute coronary syndrome	0.022	0	0.022
Adrenal insufficiency	0.01	0.01	0.01
Adverse reaction	0.022	0.009	0.022
Affect lability	0.08	0	0.08
Ageusia	0.01	0	0.01
Aggression	0.069	0	0.069
Aggressive reaction	0.04	0	0.04
Agitation	0.24	0	0.24
Agranulocytosis	0.205	0	0.205
Akathisia	0.23	0	0.23
Akinesia	0.086	0	0.086
Alanine aminotransferase increased	0.66	0	0.66
Albumin low	0.21	0	0.21
Albumin urine present	0.04	0.04	0.04
Albuminuria	0.0571	0	0.0571429
Alopecia	0.98	0	0.98
Altered state of consciousness	0.03	0.003	0.03
Altered visual depth perception	0	0	0
Alveolitis	0.0294	0.0294	0.0294
Amblyopia	0.09	0	0.09
Amenorrhoea	0.0714	0	0.0714286
Amnesia	0.1	0	0.1
Amylase increased	0.17	0.0123457	0.17
Anaemia	0.49	0	0.49
Anal haemorrhage	0.0426	0	0.0425532
Anger	0.063	0	0.063
Angina pectoris	0.11	0	0.11
Angina pectoris aggravated	0.02	0.011	0.02
Angina unstable	0.027	0.027	0.027
Angioedema	0.001	0.001	0.001
Angiopathy	0.56	0	0.56
Ankle edema	0.0561	0.020979	0.0560748
Anogenital warts	0.01	0.01	0.01
Anorectal discomfort	0.0877	0.05	0.0877193
Anorectal disorder	0.02	0.02	0.02
Anorexia	0.47	0	0.47
Anorgasmia	0.01	0	0.01
Anxiety	0.249	0	0.249
Anxiety NEC	0.0255	0.0254777	0.0254777
Anxiety symptoms NOS	0.03	0.03	0.03
Apathy	0.01	0	0.01
Aphasia	0.183	0	0.183333
Aphthous stomatitis	0	0	0
Apnoea	0.26	0.26	0.26
Apocrine and eccrine gland disorders	0.04	0.038	0.04
Appendicitis	0.006	0.006	0.006
Appetite disorder	0.07	0	0.07
Application and instillation site reactions	0.19	0.04	0.19
Application site dryness	0.00342	0.00342466	0.00342466
Application site erythema	0.023	0.00342466	0.023
Application site irritation	0	0	0
Application site papules	0	0	0
Application site paraesthesia	0.00342	0.00342466	0.00342466
Application site pruritus	0.12	0	0.12
Application site rash	0.06	0.0049505	0.06
Application site reaction	0.586	0	0.586207
Application site vesicles	0	0	0
Arrhythmia	0.08	0	0.08
Arterial anomaly	0.00293	0.00292969	0.00292969
Arthralgia	0.371	0	0.3714
Arthritis	0.0718	0	0.0717703
Arthropathy	0.154	0	0.1543
Artificial kidney clotting during dialysis	0.042	0.042	0.042
Ascites	0.0943	0.0943396	0.0943396
Aspartate aminotransferase increased	0.46	0	0.46
Asthenia	0.55	0	0.55
Asthenic conditions	0.444	0.05	0.444
Asthenopia	0	0	0
Asthma	0.417	0	0.417
Ataxia	0.1	0	0.1
Atelectasis	0.03	0.01	0.03
Atrial fibrillation	0.051	0	0.051
Atrial flutter	0.00794	0.00793651	0.00793651
Atrioventricular block	0.027	0	0.027
Atrioventricular block complete	0.047	0.047	0.047
Atrioventricular block first degree	0.05	0	0.05
Atrioventricular block second degree	0.012	0	0.012
Auditory disorder NOS	0.032	0.01	0.032
Automatism	0.01	0.01	0.01
Autonomic neuropathy	0.14	0.05	0.14
Back pain	0.243	0	0.243
Bacteraemia	0	0	0
Bacterial infection	0	0	0
Bacteriuria	0.016	0.016	0.016
Bad taste	0	0	0
Balance disorder	0.05	0	0.05
Balanitis	0	0	0
Benign neoplasm of skin	0.014	0.01	0.014
Benign prostatic hyperplasia	0.01	0.01	0.01
Bilirubin total increased	0.1	0	0.1
Binge eating	0	0	0
Bipolar I disorder	0	0	0
Bizarre dreams	0	0	0
Bladder and urethral symptoms	0.014	0.01	0.014
Bladder pain	0.045	0	0.045
Blepharitis	0.01	0	0.01
Blindness	0.0003	0.0003	0.0003
Block heart	0.008	0.001	0.008
Blood albumin decreased	0.21	0	0.21
Blood alkaline phosphatase increased	0.66	0	0.66
Blood amylase increased	0.0123	0.0123457	0.0123457
Blood and lymphatic system disorders	0.0733	0.006	0.0732759
Blood bilirubin increased	0.14	0	0.14
Blood calcium decreased	0.12	0	0.12
Blood cortisol decreased	0.00388	0	0.00387597
Blood creatine phosphokinase increased	0.52	0	0.52
Blood creatinine increased	0.38	0	0.38
Blood glucose decreased	0.03	0	0.03
Blood glucose increased	0.35	0	0.35
Blood in stool	0.034	0.034	0.034
Blood insulin increased	0.01	0.01	0.01
Blood lactate dehydrogenase increased	0.0357	0	0.0357143
Blood magnesium decreased	0.14	0	0.14
Blood phosphorus decreased	0.14	0	0.14
Blood potassium decreased	0.05	0	0.05
Blood potassium increased	0.11	0	0.11
Blood pressure diastolic decreased	0	0	0
Blood pressure increased	0.019	0	0.019
Blood prolactin increased	0.003	0.003	0.003
Blood triglycerides increased	0.53	0	0.53
Blood urea increased	0.076	0	0.076
Blood uric acid increased	0.02	0.007	0.02
Body odor	0	0	0
Body temperature increased	0.435	0	0.435
Bone disorder	0.025	0.007	0.025
Bone pain	0.754	0	0.754
Bradycardia	0.106	0	0.105708
Bradykinesia	0.086	0	0.086
Bradyphrenia	0.031	0.014	0.031
Brain abscess	0.04	0.04	0.04
Brain oedema	0.192	0.01	0.191667
Breast cancer	0.01	0	0.01
Breast disorder	0.47	0	0.47
Breast enlargement	0.0345	0	0.0344828
Breast neoplasm	0.069	0.0689655	0.0689655
Breast pain	0.096	0	0.096
Breast pain female	0	0	0
Breast tenderness	0.06	0	0.06
Breath odour	0.00301	0.00301205	0.00301205
Bronchial obstruction	0.01	0	0.01
Bronchitis	0.15	0	0.15
Bronchopneumonia	0.0129	0.012931	0.012931
Bronchospasm	0.02	0	0.02
Bronchospasm paradoxical	0.019	0.019	0.019
Bruxism	0.006	0.005	0.006
Buffalo hump	0.0187	0	0.0186916
Bullous eruption	0.01	0.00303951	0.01
Bundle branch block	0.02	0	0.02
Burning feeling vagina	0.022	0.022	0.022
Burning sensation	0.0139	0	0.0138889
Bursitis	0.006	0	0.006
Calcium low	0.12	0	0.12
Calculus of kidney	0	0	0
Candida infection	0.083	0	0.083
Carcinoma	0.031	0.031	0.031
Carcinoma breast	0.01	0	0.01
Cardiac arrest	0.027	0.00390625	0.027
Cardiac disorder	0.116	0	0.116379
Cardiac failure	0.315	0	0.315
Cardiac failure congestive	0.055	0	0.055
Cardiac fibrillation	0	0	0
Cardiac murmur	0	0	0
Cardiac pain	0.046	0	0.046
Cardiac tamponade	0.0106	0.00790314	0.0106458
Cardiac valve disease	0.0235	0.00478469	0.0235097
Cardioactive drug level above therapeutic	0.00794	0.00793651	0.00793651
Cardioactive drug level increased	0.04	0.01	0.04
Cardiogenic shock	0.02	0	0.02
Cardiovascular disorder	0.06	0	0.06
Carpal tunnel syndrome	0.003	0	0.003
Cataplexy	0.01	0.01	0.01
Cataract	0.057	0	0.057
Cataract unilateral	0	0	0
Cauda equina syndrome	0.045	0.038	0.045
Cellulitis	0.06	0	0.06
Cerebellar syndrome	0	0	0
Cerebral haemorrhage	0.04	0	0.04
Cerebral ischaemia	0.005	0.005	0.005
Cerebration impaired	0.14	0	0.14
Cerebrovascular accident	0.032	0	0.032
Cervical polyp	0.0191	0.0191388	0.0191388
Chest discomfort	0.0625	0	0.0625
Chest pain	0.298	0	0.298
Chest pressure	0.01	0	0.01
Chest tightness	0.01	0	0.01
Chills	0.39	0	0.39
Cholecystitis	0.044	0.044	0.0440252
Cholelithiasis	0	0	0
Chromaturia	0.06	0	0.06
Chronic obstructive pulmonary disease	0.13	0.13	0.13
Circumoral paresthesia	0.004	0	0.004
Claudication	0.03	0	0.03
Coagulopathy	0.01	0	0.01
Cognitive disorder	0.21	0.205	0.21
Cogwheel rigidity	0	0	0
Cold hands & feet	0	0	0
Cold sweat	0.011	0.011	0.011
Cold symptoms	0.05	0.017	0.05
Colitis	0.27	0	0.27
Coma	0.05	0.05	0.05
Common cold	0.214	0	0.213953
Confusional state	0.208	0	0.208333
Congenital arterial malformation	0.00293	0.00292969	0.00292969
Congenital eye disorder	0.01	0.01	0.01
Congenital genitourinary abnormality	0	0	0
Conjunctival oedema	0.0667	0.0666667	0.0666667
Conjunctivitis	0.036	0	0.036
Connective tissue disorder	0.35	0	0.35
Consciousness abnormal	0.03	0.029	0.03
Constipation	0.386	0	0.386
Constipation aggravated	0.00847	0.00511073	0.00847458
Contusion	0.146	0	0.146
Convulsion	0.375	0	0.375
Coordination abnormal	0.18	0	0.18
COPD exacerbation	0.13	0.13	0.13
Corneal lesion	0	0	0
Corneal staining	0.013	0.013	0.013
Coronary artery disease	0.000977	0.000976562	0.000976562
Coronary artery occlusion	0.00195	0.00195312	0.00195312
Cough	0.512	0	0.5125
Cough increased	0.473	0	0.473
Cramp muscle	0.211	0	0.211429
Cramps of lower extremities	0.13	0	0.13
Creatine phosphokinase increased	0.52	0	0.52
Creatinine increased	0.38	0	0.38
Creatinine renal clearance decreased	0.024	0	0.024
Crying	0	0	0
Cushingoid	0.0492	0	0.0491803
Cushing's syndrome	0.242	0.05	0.242424
Cyst	0.0345	0.0344828	0.0344828
Cystitis	0.045	0	0.045
Cystitis noninfective	0.045	0	0.045
Cytomegalovirus infection	0.054	0.008	0.054
Dandruff	0	0	0
Deafness	0.031	0.005	0.031
Decreased appetite	0.47	0	0.47
Decubitus ulcer	0.011	0.011	0.011
Deep vein thrombosis	0.0429	0.002	0.0428571
Defaecation urgency	0.0921	0.0921053	0.0921053
Defect conduction intraventricular	0.04	0	0.04
Dehydration	0.0429	0	0.0428571
Delusion	0.0139	0	0.0138889
Depersonalisation	0.019	0	0.019
Depressed level of consciousness	0.003	0	0.003
Depressed mood	0.026	0	0.026
Depression	0.37	0	0.37
Depression aggravated	0.01	0.01	0.01
Depressive disorder	0.03	0.029	0.03
Derealisation	0.038	0.01	0.038
Dermatitis	0.37	0	0.37
Dermatitis acneiform	0.07	0	0.07
Dermatitis atopic	0.03	0.03	0.03
Dermatitis bullous	0.01	0	0.01
Dermatitis contact	0.0181	0	0.0180723
Dermatitis exfoliative	0	0	0
Device capturing issue	0.01	0	0.01
Device malfunction	0.042	0.042	0.042
Diabetes mellitus	0.16	0	0.16
Diabetes mellitus exacerbated	0.081	0.081	0.081
Diabetic neuropathy	0.03	0.03	0.03
Diabetic vascular disorder	0.09	0.09	0.09
Diarrhoea	0.55	0	0.55
Digoxin level increased	0.04	0.01	0.04
Diplopia	0.09	0	0.09
Discomfort	0.55	0	0.55
Disinhibition	0.02	0	0.02
Disorder sight	0.0147	0.01	0.0146699
Disorientation	0.02	0	0.02
Disseminated intravascular coagulation	0	0	0
Distention	0.005	0.004	0.005
Distress	0.02	0.02	0.02
Disturbance in attention	0.14	0	0.14
Disturbance in sexual arousal	0.08	0	0.08
Dizziness	0.369	0	0.369
Dizziness postural	0.14	0	0.14
Dreaming excessive	0.17	0.17	0.17
Drooling	0.05	0	0.05
Drowsiness	0.427	0	0.427
Drug dependence	0.02	0	0.02
Drug intolerance	0	0	0
Drug level increased	0.037	0.002	0.037
Drug withdrawal syndrome	0.119	0	0.119403
Dry eye	0.03	0	0.03
Dry mouth	0.35	0	0.35
Dry skin	0.0686	0	0.0686
Dry throat	0.01	0	0.01
Duodenal ulcer haemorrhage	0.0411	0.0411311	0.0411311
Dysaesthesia	0.033	0.029	0.033
Dysarthria	0.063	0	0.063
Dyschezia	0.0532	0	0.0531915
Dysentery	0.044	0.044	0.044
Dysgeusia	0.0971	0	0.0971429
Dyskinesia	0.31	0	0.31
Dyslipidaemia	0.034	0	0.034
Dysmenorrhoea	0.14	0	0.14
Dysmetria	0	0	0
Dyspepsia	0.34	0	0.34
Dyspeptic signs and symptoms	0.038	0.01	0.038
Dysphagia	0.1	0	0.1
Dysphasia	0	0	0
Dysphonia	0.09	0	0.09
Dysphoria	0.01	0	0.01
Dyspnoea	0.385	0	0.385
Dyspnoea exacerbated	0.0606	0.03	0.0606061
Dyspnoea exertional	0.07	0	0.07
Dysthymic disorder	0.03	0.029	0.03
Dystonia	0	0	0
Dystonic reaction	0	0	0
Dysuria	0.09	0	0.09
Ear and labyrinth disorders	0.11	0	0.11
Ear disorder	0.06	0	0.06
Ear infection	0.04	0	0.04
Ear pain	0.088	0	0.088
Ecchymosis	0.03	0	0.03
Eczema	0.03	0	0.03
Edema cerebral	0.19	0.01	0.19
Edema of lower extremities	0.0333	0.007	0.0333333
Ejaculation delayed	0.01	0	0.01
Ejaculation disorder	0.181	0	0.180894
Ejaculation failure	0.02	0	0.02
Electrocardiogram abnormal	0.034	0	0.034
Electrocardiogram abnormal specific	0.01	0.01	0.01
Electrocardiogram change	0	0	0
Electrocardiogram QT corrected interval prolonged	0.03	0.01	0.03
Electrocardiogram QT prolonged	0.03	0.01	0.03
Electrocardiogram ST segment depression	0	0	0
Electrocardiogram T wave abnormal	0.01	0	0.01
Electrocardiogram T wave inversion	0.01	0.01	0.01
Electroencephalogram abnormal	0	0	0
Emotional disorder	0.01	0.01	0.01
Emotional distress	0.02	0.02	0.02
Endocrine disorder	0.229	0.036	0.228571
Endometrial disorder	0.0821	0.014	0.0820896
Endometrial hyperplasia	0	0	0
Endophthalmitis	0.009	0	0.009
Enlargement abdomen	0.1	0	0.1
Enuresis	0.1	0	0.1
Enzyme abnormality	0.032	0.032	0.032
Eosinophilia	0.25	0	0.25
Epigastric discomfort	0.028	0.028	0.028
Epigastric pain	0.017	0.017	0.017
Epistaxis	0.13	0	0.13
Erectile dysfunction	0.122	0	0.122
Eructation	0.15	0	0.15
Eruption	0.0201	0.0201459	0.0201459
Erythema	0.05	0	0.05
Euphoric mood	0.01	0	0.01
Exacerbation of asthma	0.085	0.085	0.085
Excitement	0.057	0.01	0.057
Excoriation	0	0	0
Exfoliative rash	0.09	0	0.09
Exposure to poisonous plant	0	0	0
Exposure to toxic agent	0	0	0
Expressive language disorder	0.016	0.01	0.016
Extrapyramidal disorder	0.26	0	0.26
Extrapyramidal symptoms	0.16	0	0.16
Extrasystoles	0.01	0	0.01
Extravasation	0.02	0.01	0.02
Eye disorder	0.14	0	0.14
Eye haemorrhage	0.0003	0.0003	0.0003
Eye infection	0.01	0.01	0.01
Eye irritation	0.006	0.006	0.006
Eye oedema	0	0	0
Eye pain	0.02	0	0.02
Eye redness	0	0	0
Face oedema	0.05	0	0.05
Facial paralysis	0.0417	0.0416667	0.0416667
Faecal incontinence	0.0278	0	0.0277778
Fall	0.04	0	0.04
Fasting	0.03	0.003	0.03
Fasting hyperglycaemia	0.08	0	0.08
Fatigue	0.55	0	0.55
Fear	0.01	0.01	0.01
Febrile neutropenia	0	0	0
Feeling abnormal	0.55	0	0.55
Feeling cold	0.04	0	0.04
Feeling drunk	0.01	0	0.01
Feeling hot	0.08	0	0.08
Feeling jittery	0.04	0	0.04
Feeling strange	0	0	0
Flank pain	0	0	0
Flat affect	0.01	0	0.01
Flatulence	0.3	0	0.3
Flu symptoms	0.186	0.02	0.186047
Fluid overload	0.17	0	0.17
Fluid retention	0.3	0	0.3
Flushing	0.433	0	0.432958
Foetal distress syndrome	0.0385	0	0.0384615
Foetor hepaticus	0.003	0.003	0.003
Folliculitis	0.02	0.019	0.02
Foot edema	0.019	0	0.019
Forced expiratory volume decreased	0.287	0.286957	0.286957
Fracture	0.008	0.008	0.008
Frequent bowel movements	0	0	0
Fullness abdominal	0.02	0.02	0.02
Fungal infection	0.0115	0	0.0114943
Fungal skin infection	0.02	0	0.02
Gait disturbance	0.07	0	0.07
Galactorrhoea	0	0	0
Gamma-glutamyltransferase increased	0.03	0	0.03
Gastric atony	0.05	0.05	0.05
Gastric disorder	0.044	0.042	0.044
Gastritis	0.24	0	0.24
Gastroenteritis	0.06	0	0.06
Gastrointestinal candidiasis	0	0	0
Gastrointestinal discomfort	0.03	0.008	0.03
Gastrointestinal disorder	0.642	0	0.642241
Gastrointestinal haemorrhage	0.08	0	0.08
Gastrointestinal infection	0.01	0.01	0.01
Gastrointestinal pain	0.44	0	0.440252
Gastrointestinal symptom NOS	0	0	0
Gastrooesophageal reflux disease	0.04	0	0.04
Generalised oedema	0.05	0	0.05
Genital candidiasis	0.0213	0.0212766	0.0212766
Genital disorder female	0.0621	0	0.0621469
Genital disorder male	0	0	0
Genital infection fungal	0.032	0.003	0.032
Gingival bleeding	0.00363	0.00363196	0.00363196
Gingival disorder	0.029	0.015	0.029
Gingival hyperplasia	0.023	0	0.023
Gingival pain	0.0279	0.027907	0.027907
Gingivitis	0.01	0	0.01
Glossitis	0	0	0
Glossodynia	0.04	0	0.04
Glucose decreased	0.03	0	0.03
Glucose increased	0.35	0	0.35
Glycosuria	0.03	0.007	0.03
Gout	0.062	0	0.062
Grand mal convulsion	0.0417	0	0.0416667
Gravitational oedema	0.03	0	0.03
Gynaecomastia	0.0714	0	0.0714286
Haematemesis	0.00391	0	0.00390625
Haematochezia	0.034	0.034	0.034
Haematoma	0.109	0	0.109091
Haematuria	0.1	0	0.1
Haemoglobin	0.187	0	0.187
Haemoglobin decreased	0.79	0	0.79
Haemoglobin increased	0	0	0
Haemoptysis	0.237	0.02	0.237
Haemorrhage	0.187	0	0.187
Haemorrhage intracranial	0.003	0	0.003
Haemorrhagic stroke	0.001	0.001	0.001
Haemorrhoids	0.03	0	0.03
Hair colour changes	0.03	0	0.03
Hallucination	0.05	0	0.05
Hand swelling	0.09	0.09	0.09
Hangover	0.02	0.011	0.02
Head injury	0.01	0	0.01
Headache	0.53	0	0.53
Headache aggravated	0	0	0
Hearing impaired	0.032	0.005	0.032
Heartburn	0.08	0	0.08
Hemiplegia	0.442	0.441667	0.441667
Hepatic enzyme abnormal	0.1	0.02	0.1
Hepatic enzyme increased	0.041	0	0.041
Hepatic function abnormal	0.08	0	0.08
Hepatic steatosis	0.02	0.02	0.02
Hepatobiliary disease	0.05	0	0.05
Hepatocellular injury	0.003	0.003	0.003
Hernia	0.01	0.01	0.01
Herpes simplex	0.08	0.03	0.08
Herpes virus infection	0.08	0.038	0.08
Herpes zoster	0.031	0	0.031
Hiccups	0.037	0	0.037
Hirsutism	0.08	0	0.08
Hoarseness	0.01	0	0.01
Hormone level abnormal	0	0	0
Hostility	0.14	0.006	0.14
Hot flush	0.48	0	0.48
Hydrocephalus	0.02	0.02	0.02
Hyperacusis	0.01	0	0.01
Hyperaemia	0.014	0.009	0.014
Hyperaesthesia	0.01	0	0.01
Hyperbilirubinaemia	0.17	0.0036036	0.17
Hypercalcaemia	0.03	0	0.03
Hypercholesterolaemia	0.46	0	0.46
Hyperglycaemia	0.509	0	0.509
Hyperhidrosis	0.31	0	0.31
Hyperkalaemia	0.27	0.001	0.27
Hyperkeratosis	0.01	0	0.01
Hyperkinesia	0.089	0	0.089
Hyperlipidaemia	0.23	0	0.23
Hypermagnesaemia	0.02	0	0.02
Hypernatraemia	0.25	0	0.25
Hyperpyrexia	0.03	0.03	0.03
Hyperreflexia	0.03	0.01	0.03
Hypersensitivity	0.06	0	0.06
Hypersomnia	0.009	0	0.009
Hypertension	0.48	0	0.48
Hypertensive crisis	0.05	0	0.05
Hypertonia	0.06	0	0.06
Hypertrichosis	0.03	0.01	0.03
Hypertriglyceridaemia	0.53	0	0.53
Hyperuricaemia	0.02	0.007	0.02
Hyperventilation	0.145	0.027	0.145
Hypoaesthesia	0.0714	0	0.0714286
Hypoaesthesia oral	0.01	0	0.01
Hypoalbuminaemia	0.47	0	0.47
Hypocalcaemia	0.27	0	0.27
Hypocholesterolaemia	0.025	0.025	0.025
Hypoglycaemia	0.3	0	0.3
Hypokalaemia	0.198	0	0.198
Hypokinesia	0.139	0	0.139
Hypomagnesaemia	0.04	0	0.04
Hyponatraemia	0.24	0	0.24
Hypophosphataemia	0.19	0	0.19
Hypoproteinaemia	0.0714	0.0714286	0.0714286
Hyporeflexia	0.01	0	0.01
Hypotension	0.3	0	0.3
Hypothyroidism	0.01	0	0.01
Hypoventilation	0.0426	0.0425532	0.0425532
Hypovolaemia	0.02	0.002	0.02
Hypoxia	0.0659	0.02	0.0659134
Ill-defined disorder	0.55	0	0.55
Immune system disorder	0.23	0.004	0.23
Immunoglobulins increased	0	0	0
Impaired gastric emptying	0.05	0.05	0.05
Impaired healing	0.117	0	0.116667
Incontinence	0.01	0.006	0.01
Increased appetite	0.23	0	0.23
Increased bronchial secretion	0.397	0.012	0.397
Infection	0.595	0	0.594828
Infestation	0.595	0	0.594828
Infestation NOS	0.595	0	0.594828
Inflammation	0.03	0	0.03
Inflicted injury	0.0694	0.00442478	0.0694444
Influenza	0.4	0	0.4
Influenza like illness	0.81	0	0.81
Influenza viral infections	0.1	0.0980861	0.1
Influenza-like symptoms	0.2	0	0.2
Infusion site erythema	0	0	0
Infusion site pain	0.27	0.0144928	0.27
Infusion site phlebitis	0.0145	0.0144928	0.0144928
Infusion site reaction	0.27	0	0.27
Inguinal hernia	0	0	0
Initial insomnia	0.028	0	0.028
Injection site dermatitis	0	0	0
Injection site erythema	0.027	0	0.027
Injection site haemorrhage	0.004	0.004	0.004
Injection site inflammation	0.49	0.08	0.49
Injection site irritation	0.04	0.011	0.04
Injection site mass	0.27	0	0.27
Injection site pain	0.73	0	0.73
Injection site pruritus	0.4	0.008	0.4
Injection site reaction	0.59	0	0.59
Injection site swelling	0.004	0.004	0.004
Injection site urticaria	0.05	0	0.05
Injury	0.2	0	0.2
Insomnia	0.418	0	0.418
Insomnia exacerbated	0.02	0.02	0.02
Insulin C-peptide increased	0.01	0.01	0.01
Intentional injury	0	0	0
Intermittent claudication	0.06	0	0.06
International normalised ratio increased	0.17	0.0258065	0.17
Intracranial pressure increased	0.02	0.0166667	0.02
Intraventricular haemorrhage	0.24	0.1	0.24
Irritability	0.301	0	0.301
Jaundice	0.01	0.01	0.01
Joint related signs and symptoms	0.03	0.019	0.03
Joint sprain	0.01	0.01	0.01
Joint stiffness	0.02	0	0.02
Joint swelling	0.0561	0	0.0560748
Keratitis	0	0	0
Keratoconjunctivitis sicca	0.03	0	0.03
Kidney function abnormal	0.023	0.002	0.023
Knee pain	0.04	0.04	0.04
Laboratory test abnormal	0.04	0	0.04
Labyrinthitis	0	0	0
Laceration	0.02	0.01	0.02
Lacrimal disorder	0.02	0	0.02
Lacrimal structural disorder	0	0	0
Lacrimation	0.08	0.01	0.08
Lacrimation abnormal NOS	0.02	0	0.02
Lacrimation increased	0.08	0	0.08
Lactation female	0	0	0
Lactic dehydrogenase activity increased	0.0357	0	0.0357143
Laryngeal pain	0.142	0	0.141667
Laryngitis	0.014	0	0.014
Leg edema	0.01	0.002	0.01
Leg pain	0.04	0	0.04
Lenticular opacities	0.004	0.004	0.004
Lethargy	0.088	0	0.088
Leukocytosis	0.041	0	0.041
Leukoderma	0.01	0	0.01
Leukopenia	0.21	0	0.21
Leukorrhea	0.0735	0	0.0735294
Libido decreased	0.08	0	0.08
Libido increased	0.041	0.04	0.041
Ligament sprain	0.01	0.01	0.01
Lightheadedness	0.369	0	0.369
Limb injury	0.01	0	0.01
Lipase increased	0.19	0.05	0.19
Lipodystrophy	0.005	0.005	0.005
Lipodystrophy acquired	0.005	0.005	0.005
Lipohypertrophy	0.0187	0	0.0186916
Liver disorder	0.003	0.003	0.003
Liver function test abnormal	0.1	0	0.1
Local reaction	0.34	0.34	0.34
Local swelling	0.09	0	0.09
Local throat irritation	0.004	0.002	0.004
Logorrhoea	0.01	0.01	0.01
Loose stools	0.15	0	0.15
Loss of consciousness	0.09	0	0.09
Low back pain	0	0	0
Lower respiratory tract infection	0.094	0	0.094
Lung disorder	0.313	0	0.313
Lung infection	0.048	0.013	0.048
Lymphadenopathy	0.12	0	0.12
Lymphocele	0.06	0.06	0.06
Lymphocyte count decreased	0.28	0	0.28
Lymphoma	0	0	0
Lymphopenia	0.53	0	0.53
Lymphoproliferative disorder	0.032	0	0.032
Macule	0	0	0
Malaise	0.55	0	0.55
Malignant hypertension	0.05	0.01	0.05
Malignant melanoma	0.031	0	0.031
Malignant neoplasm progression	0.2	0.2	0.2
Malnutrition	0.384	0	0.383621
Mania	0.06	0.0268949	0.06
Manic psychosis	0.06	0.0268949	0.06
Mediastinal disorder	0.5	0	0.5
Melaena	0.03	0	0.03
Melanoma skin	0.031	0.031	0.031
Memory impairment	0.221	0	0.221
Menopausal symptoms	0.48	0	0.48
Menorrhagia	0.05	0	0.05
Menstrual disorder	0.26	0	0.26
Menstruation delayed	0.01	0.01	0.01
Menstruation irregular	0.19	0	0.19
Mental deficiency	0	0	0
Mental disability	0.14	0	0.14
Mental disorder	0.418	0	0.418103
Mental impairment disorders	0.018	0	0.018
Mental retardation	0.057	0	0.057
Metabolic disorder	0.209	0.0124368	0.208706
Metastasis	0.244	0.03	0.244
Metrorrhagia	0.0446	0	0.044586
Mg reduced	0.14	0	0.14
Micturition burning	0.04	0.04	0.04
Micturition disorder	0.02	0.01	0.02
Micturition urgency	0.0139	0	0.0138889
Middle insomnia	0.08	0.009	0.08
Migraine	0.222	0	0.222
Miosis	0	0	0
Mood alteration NOS	0.0247	0.0247253	0.0247253
Mood swings	0.08	0	0.08
Motion sickness	0	0	0
Motor dysfunction	0	0	0
Mouth ulceration	0.23	0	0.23
Movement disorder	0	0	0
Mucosal inflammation	0.05	0	0.05
Multiple congenital abnormalities	0	0	0
Multiple fractures	0.008	0.008	0.008
Multiple sclerosis	0.00833	0.00833333	0.00833333
Multiple sclerosis relapse	0.03	0.03	0.03
Muscle atrophy	0.005	0.005	0.005
Muscle contractions involuntary	0.01	0	0.01
Muscle injury	0.01	0.01	0.01
Muscle rigidity	0.053	0	0.053
Muscle spasms	0.211	0	0.211429
Muscle stiffness	0.033	0.033	0.033
Muscle strain	0.01	0	0.01
Muscle tightness	0	0	0
Muscle twitching	0.118	0	0.118
Muscular weakness	0.0889	0	0.0888889
Musculoskeletal chest pain	0.04	0.003	0.04
Musculoskeletal discomfort	0.57	0	0.57
Musculoskeletal disorder	0.325	0.004	0.324913
Musculoskeletal pain	0.32	0	0.32
Musculoskeletal stiffness	0.033	0	0.033
Myalgia	0.57	0	0.57
Myasthenia	0.0889	0	0.0888889
Mydriasis	0.004	0	0.004
Myocardial infarction	0.022	0	0.022
Myocardial ischaemia	0.00862	0.00862069	0.00862069
Myoclonus	0	0	0
Myopia	0	0	0
Nail abnormality NOS	0	0	0
Nail disorder	0.02	0	0.02
Nasal burning	0.026	0.012	0.026
Nasal congestion	0.165	0	0.165
Nasal discomfort	0.0484	0	0.0484429
Nasal dryness	0.00498	0	0.00497512
Nasal inflammation	0.02	0.02	0.02
Nasal irritation	0.036	0	0.036036
Nasal passage irritation	0.036	0.022	0.036
Nasal septum ulceration	0.00258	0.00258398	0.00258398
Nasal ulcer	0.012	0	0.012
Nasopharyngitis	0.254	0	0.253731
Nausea	0.518	0	0.518
Neck injury	0	0	0
Neck pain	0.08	0	0.08
Neck stiffness	0.01	0	0.01
Neck tightness	0	0	0
Necrotising colitis	0.0256	0.025641	0.025641
Necrotising enterocolitis neonatal	0.0256	0.025641	0.025641
Necrotizing enterocolitis	0.0256	0.025641	0.025641
Neoplasm	0.01	0	0.01
Neoplasm malignant	0.031	0	0.031
Neoplasm malignant aggravated	0.2	0.2	0.2
Neoplasm skin	0	0	0
Nephrolithiasis	0	0	0
Nephropathy	0.0389	0.00233191	0.0388651
Nerve root lesion	0.019	0.019	0.019
Nervous system disorder	0.595	0	0.594828
Nervousness	0.185	0	0.185
Neuralgia	0.019	0	0.019
Neuropathy	0.1	0	0.1
Neuropathy peripheral	0.242	0	0.242054
Neurosis	0	0	0
Neurotoxicity	0.13	0.05	0.13
Neutropenia	0.41	0	0.41
Neutrophil count decreased	0.061	0.00277778	0.061
Night sweats	0.17	0.004	0.17
Nightmare	0.057	0	0.057
Nipple pain	0	0	0
Nocturia	0.008	0	0.008
Non-cardiac chest pain	0.03	0	0.03
Non-Hodgkin's lymphoma	0	0	0
NPN increased	0.05	0.002	0.05
Nuchal rigidity	0.01	0	0.01
Numbness	0.02	0.004	0.02
Nystagmus	0.093	0	0.093
Ocular hyperaemia	0	0	0
Oculogyration	0	0	0
Oculogyric crisis	0.01	0	0.01
Oedema	0.54	0	0.54
Oedema peripheral	0.48	0	0.48
Oesophageal ulcer	0.015	0	0.015
Oesophagitis	0.07	0.006	0.07
Oliguria	0.1	0	0.1
Oral candidiasis	0.07	0	0.07
Oral fungal infection	0	0	0
Oral herpes	0.02	0.0166667	0.02
Oral pain	0.06	0.06	0.06
Orgasm abnormal	0.01	0	0.01
Oropharyngeal candidiasis	0	0	0
Oropharyngeal discomfort	0.09	0	0.09
Oropharyngeal pain	0.183	0	0.182692
Orthostatic hypotension	0.48	0	0.48
Osteoarthritis	0.154	0	0.1543
Otitis	0.037	0.025	0.037
Otitis externa	0	0	0
Otitis media	0.58	0	0.58
Otitis media acute	0	0	0
Pain	0.49	0	0.49
Pain in arm	0.014	0	0.014
Pain in extremity	0.1	0	0.1
Pain in jaw	0.05	0	0.05
Pain localised	0.09	0.015	0.09
Pain of lower extremities	0.02	0.02	0.02
Pallor	0.06	0	0.06
Palpitations	0.156	0	0.156
Pancreatitis	0	0	0
Pancytopenia	0	0	0
Panic attack	0.003	0.003	0.003
Panic reaction	0	0	0
Panophthalmitis	0.009	0.009	0.009
Paraesthesia	0.114	0	0.114286
Paraesthesia oral	0.005	0	0.005
Paranoia	0	0	0
Paranoid reaction	0	0	0
Parathyroid disorder	0.02	0.02	0.02
Paresis	0	0	0
Parkinsonism	0.15	0	0.15
Parkinsonism aggravated	0.148	0.148	0.148
Parkinson's disease	0.01	0.01	0.01
Parosmia	0.01	0	0.01
Pelvic pain	0.06	0	0.06
Penis disorder	0	0	0
Pericardial effusion	0.00293	0.00292969	0.00292969
Pericardial haemorrhage	0	0	0
Pericarditis	0	0	0
Perineal pain	0	0	0
Periodontitis	0.007	0.007	0.007
Periorbital oedema	0.145	0	0.145
Peripheral coldness	0.05	0	0.05
Peripheral ischaemia	0	0	0
Peripheral sensory neuropathy	0.0517	0	0.0517241
Peripheral swelling	0.003	0.003	0.003
Peripheral vascular disorder	0.024	0.024	0.024
Peritonitis	0	0	0
Personality disorder	0.09	0	0.09
Pharyngitis	0.393	0	0.393
Pharyngitis streptococcal	0.03	0	0.03
Pharyngolaryngeal pain	0.142	0	0.141667
Phlebitis	0.05	0.003	0.05
Phlebitis superficial	0	0	0
Phonological disorder	0.01	0.01	0.01
Phosphatase alkaline increased	0.66	0	0.66
Phosphate low	0.14	0	0.14
Phosphorus low	0.11	0	0.11
Photosensitivity	0	0	0
Photosensitivity reaction	0	0	0
Pica	0.061	0.061	0.061
Piloerection	0	0	0
Pitting edema	0.003	0.003	0.003
Platelet count decreased	0.11	0	0.11
Pleural effusion	0.091	0.01	0.091
Pleuritic pain	0	0	0
Pneumocystis jirovecii pneumonia	0	0	0
Pneumonia	0.17	0	0.17
Pneumonia aspiration	0.005	0.005	0.005
Pneumonia bacterial	0	0	0
Pneumothorax	0.03	0.01	0.03
Pollakiuria	0.07	0	0.07
Polyuria	0.0318	0	0.0318182
Post procedural diarrhoea	0	0	0
Post procedural haemorrhage	0.06	0.006	0.06
Post procedural oedema	0.32	0.32	0.32
Post procedural pain	0.018	0.0179641	0.0179641
Post procedural swelling	0.01	0	0.01
Postictal state	0.01	0.01	0.01
Postoperative hemorrhage	0.00608	0.006	0.00607903
Post-traumatic pain	0.00556	0.00555556	0.00555556
Posture abnormal	0.008	0.008	0.008
Potassium increased	0.11	0	0.11
Potassium low	0.05	0	0.05
Prehypertension	0.54	0.54	0.54
Premature ejaculation	0	0	0
Premenstrual syndrome	0.006	0.006	0.006
Presyncope	0.05	0.02	0.05
Proarrhythmia	0.019	0	0.019
Procedural pain	0.018	0	0.0179641
Procedural site reaction	0.024	0.024	0.024
Proctalgia	0.0877	0	0.0877193
Productive cough	0.13	0	0.13
Prostatic disorder	0.006	0	0.006
Prostatic specific antigen increased	0	0	0
Prostatitis	0	0	0
Protein urine present	0.34	0	0.34
Proteinuria	0.34	0	0.34
Prothrombin level decreased	0.011	0.011	0.011
Prothrombin level increased	0	0	0
Prurigo	0	0	0
Pruritus	0.36	0	0.36
Pruritus generalised	0.13	0	0.13
Pruritus genital	0	0	0
Pseudohyperkalaemia	0.0714	0	0.0714286
Pseudoparkinsonism	0.016	0.016	0.016
Psychomotor retardation	0	0	0
Psychotic disorder	0	0	0
Pulmonary congestion	0.01	0.003	0.01
Pulmonary embolism	0.0833	0.002	0.0833333
Pulmonary function test decreased	0.32	0.094	0.32
Pulmonary hypertension	0.2	0.0530303	0.2
Pulmonary oedema	0.041	0	0.041
Purpura	0.074	0	0.074
Pyelonephritis	0.215	0.03	0.215
Pyuria	0.01	0.009	0.01
Radiculopathy	0.019	0.019	0.019
Rales	0.157	0	0.156522
Rash	0.37	0	0.37
Rash both legs	0.02	0.02	0.02
Rash erythematous	0	0	0
Rash maculo-papular	0.0571	0.0571429	0.0571429
Rash pustular	0.01	0	0.01
Rash vesicular	0.00166	0.00165563	0.00165563
Reaction aggravation	0.022	0.009	0.022
Reaction gastrointestinal	0.238	0.238	0.238
Rectal discharge	0.0319	0	0.0319149
Rectal disorder	0.02	0.02	0.02
Rectal haemorrhage	0.05	0	0.05
Rectal tenesmus	0.0877	0.05	0.0877193
Red blood cell abnormality	0.006	0.006	0.006
Red blood cell disorders	0	0	0
Red blood cell sedimentation rate increased	0.0522	0.0173611	0.0521739
Redness	0.014	0.014	0.014
Regurgitation	0.043	0	0.043
Renal failure	0.05	0	0.05
Renal failure acute	0.005	0.005	0.005
Renal failure chronic	0	0	0
Renal impairment	0.04	0.002	0.04
Reproductive tract disorder	0.0833	0	0.0833333
Respiration abnormal	0.02	0.019	0.02
Respiratory depression	0.32	0.094	0.32
Respiratory disorder	0.02	0.019	0.02
Respiratory distress	0	0	0
Respiratory failure	0.0426	0.04	0.0425532
Respiratory rate decreased	0.04	0.04	0.04
Respiratory tract congestion	0.01	0.003	0.01
Respiratory tract infection	0.36	0	0.36
Restless legs syndrome	0.01	0	0.01
Retinopathy of prematurity	0	0	0
Retrograde ejaculation	0.00875	0.00875274	0.00875274
Retroperitoneal haemorrhage	0.000977	0.000976562	0.000976562
Rheumatic disorder	0.01	0	0.01
Rheumatism	0.01	0	0.01
Rheumatoid arthritis	0.023	0.023	0.023
Rhinalgia	0.01	0	0.01
Rhinitis	0.36	0	0.36
Rhinitis allergic	0.13	0.006	0.13
Rhinitis seasonal	0.02	0	0.02
Rhinorrhoea	0.13	0	0.13
Right ventricular failure	0.121	0.121212	0.121212
Rigors	0.39	0	0.39
Road traffic accident	0	0	0
Salivary hypersecretion	0.342	0	0.342
Salivation	0.342	0.342	0.342
Scab	0	0	0
Schizophrenia	0.0254	0.01	0.0253759
Sciatica	0.0111	0.01	0.0111111
Scotoma	0.0667	0.0666667	0.0666667
Seasonal allergy	0.02	0	0.02
Seborrhoeic dermatitis	0	0	0
Sensation of heat	0.08	0	0.08
Sensation of pressure	0.02	0	0.02
Sensation of warmth	0.02	0.02	0.02
Sensory disturbance	0.032	0.02	0.032
Sensory loss	0.02	0	0.02
Sepsis	0.14	0	0.14
Serum ferritin decreased	0.01	0.01	0.01
Sexual dysfunction	0.04	0	0.04
Shivering	0.0713	0.0211416	0.071298
Shock	0.09	0	0.09
Shoulder pain	0.056	0	0.056
Sinoatrial block	0.01	0	0.01
Sinus arrhythmia	0	0	0
Sinus bradycardia	0.004	0	0.004
Sinus congestion	0.06	0	0.06
Sinus disorder	0.013	0.013	0.013
Sinus headache	0.051	0.004	0.0509554
Sinus tachycardia	0.04	0.01	0.04
Sinusitis	0.184	0	0.183908
Skin breakdown	0	0	0
Skin discolouration	0.01	0	0.01
Skin disorder	0.53	0	0.53
Skin exfoliation	0.16	0	0.16
Skin laceration	0.02	0.01	0.02
Skin lesion	0.06	0.06	0.06
Skin mass	0.04	0	0.04
Skin nodule	0.04	0	0.04
Skin odour abnormal	0	0	0
Skin striae	0.0187	0	0.0186916
Skin ulcer	0.02	0	0.02
Skin wrinkling	0	0	0
Sleep attacks	0.01	0	0.01
Sleep disorder	0.18	0	0.18
Sleep disturbance	0.024	0.009	0.024
Sleep paralysis	0.01	0.01	0.01
Sleep terror	0	0	0
Sluggishness	0.01	0	0.01
Sneezing	0.0721	0	0.0720721
Sodium decreased	0.24	0	0.24
Somnambulism	0	0	0
Somnolence	0.54	0	0.54
Speech disorder	0.0833	0	0.0833333
Speech impairment NOS	0.02	0.02	0.02
Spinal cord compression	0.0556	0.038	0.0555556
Spinal disorder	0.015	0.0150215	0.0150215
Spondyloarthropathy	0.015	0.0150215	0.0150215
Spontaneous penile erection	0	0	0
Spots before eyes	0.01	0.01	0.01
Sprain	0.01	0.01	0.01
Sputum increased	0.397	0.012	0.397
Status epilepticus	0	0	0
Sticky skin	0.011	0.011	0.011
Stiffness	0.01	0	0.01
Stomach ache	0.01	0.01	0.01
Stomatitis	0.41	0	0.41
Strangury	0.09	0	0.09
Stress	0.0119	0	0.0119048
Stress symptoms	0	0	0
Stupor	0	0	0
Sudden death	0.061	0.011	0.061
Sudden onset of sleep	0.01	0.01	0.01
Suicidal ideation	0.01	0.01	0.01
Suicide attempt	0.03	0	0.03
Supraventricular tachycardia	0	0	0
Surgery	0.03	0.007	0.03
Surgical intervention	0.03	0.007	0.03
Surgical site reaction	0.024	0.024	0.024
Sweating	0.31	0	0.31
Sweating increased	0.224	0	0.224252
Swelling	0.023	0	0.023
Swollen tongue	0	0	0
Syncope	0.09	0	0.09
Synovitis	0.02	0	0.02
Tachycardia	0.268	0	0.268
Talkativeness	0.01	0.01	0.01
Taste bitter	0.024	0.00245098	0.024
Taste disorders	0	0	0
Tearfulness	0	0	0
Tenderness	0.03	0	0.03
Tendon disorder	0.031	0.031	0.031
Tendonitis	0.019	0.005	0.019
Tenosynovitis	0.05	0	0.05
Tension	0.185	0	0.185
Tension headache	0.01	0.003	0.01
Terminal insomnia	0	0	0
Testicular pain	0.01	0	0.01
Therapeutic response unexpected	0.01	0	0.01
Thinking abnormal	0.0833	0	0.0833333
Thirst	0.05	0	0.05
Throat irritation	0.142	0	0.141667
Throat sore	0.09	0	0.09
Throat tightness	0.01	0.002	0.01
Thrombocytopenia	0.305	0	0.305
Thrombocytosis	0	0	0
Thrombophlebitis	0.0917	0.000976562	0.0916667
Thrombosis	0.07	0.021	0.07
Thrombosis in device	0.042	0.042	0.042
Tinea infection	0.01	0.01	0.01
Tinea pedis	0.00278	0.00277778	0.00277778
Tingling sensation	0.03	0	0.03
Tinnitus	0.214	0	0.214
Tongue disorder	0.01	0.002	0.01
Tongue oedema	0.01	0.002	0.01
Tongue paralysis	0	0	0
Tonsillitis	0.007	0	0.007
Tooth abscess	0.0977	0	0.0976744
Tooth disorder	0.0884	0	0.0883721
Tooth infection	0.00556	0	0.00555556
Toothache	0.414	0	0.414
Torsade de pointes	0	0	0
Tracheitis	0.04	0.04	0.04
Tracheobronchitis	0.031	0.007	0.031
Transaminases increased	0.0123	0.0123457	0.0123457
Transient ischaemic attack	0.006	0.006	0.006
Transplant rejection	0.15	0.15	0.15
Trauma	0.09	0	0.09
Tremor	0.19	0	0.19
Trismus	0.09	0.03	0.09
Tuberculosis	0	0	0
Tumour pain	0.21	0.02	0.21
Tympanic membrane disorder	0.06	0.012	0.06
Ulcer	0.014	0.00387597	0.014
Ulcerative stomatitis	0.005	0.005	0.005
Unspecified disorder of autonomic nervous system	0.14	0.05	0.14
Unspecified disorder of skin and subcutaneous tissue	0.53	0	0.53
Unspecified visual loss	0.0003	0.0003	0.0003
Upper respiratory tract infection	0.52	0	0.52
Upset stomach	0.02	0	0.02
Urethral disorder	0.44	0	0.44
Urinary hesitation	0.01	0	0.01
Urinary incontinence	0.2	0	0.2
Urinary retention	0.066	0	0.066
Urinary tract disorder	0.44	0	0.44
Urinary tract infection	0.373	0	0.373
Urinary tract signs and symptoms	0.014	0.01	0.014
Urination impaired	0.01	0	0.01
Urine abnormality	0.06	0	0.06
Urine analysis abnormal	0.06	0	0.06
Urine color abnormal	0.06	0	0.06
Urine output	0.01	0.01	0.01
Urine output increased	0.0318	0	0.0318182
Urticaria	0.11	0	0.11
Uterine disorder	0.023	0.023	0.023
Uterine haemorrhage	0.04	0	0.04
Uterine hypertonus	0.012	0	0.012
Uterine neoplasm	0	0	0
Uterine pain	0.00926	0.00925926	0.00925926
Vaginal discharge	0.35	0	0.35
Vaginal dryness	0.1	0.1	0.1
Vaginal haemorrhage	0.22	0	0.22
Vaginal infection	0.069	0	0.0689655
Vaginal inflammation	0.069	0	0.0689655
Vaginal irritation	0.037	0.037037	0.037037
Vaginal moniliasis	0.071	0	0.071
Vaginal mycosis	0.032	0.032	0.032
Varicose vein	0.015	0.015	0.015
Vascular hypertensive disorders	0.02	0.014	0.02
Vascular occlusion	0.021	0.021	0.021
Vascular purpura	0.074	0	0.074
Vasodilation	0.18	0	0.18
Vasodilation procedure	0.18	0	0.18
Ventricular arrhythmia	0.136	0	0.136
Ventricular extrasystoles	0.01	0	0.01
Ventricular fibrillation	0.031	0.001	0.031
Ventricular tachycardia	0.113	0	0.113
Vertigo	0.16	0	0.16
Vesiculobullous rash	0.01	0	0.01
Vestibular disorder	0.02	0.02	0.02
VIIth nerve paralysis	0.0417	0.0416667	0.0416667
Viral diarrhoea	0.02	0	0.02
Viral infection	0.258	0	0.258
Viral upper respiratory tract infection	0.0357	0	0.0357143
Vision blurred	0.214	0	0.214
Visual disturbance	0.02	0	0.02
Visual impairment	0.06	0	0.06
Vital dye staining cornea present	0.013	0.013	0.013
Vivid dreams	0.057	0	0.057
Vomiting	0.49	0	0.49
Vulvovaginal burning sensation	0.022	0.022	0.022
Vulvovaginal candidiasis	0.071	0	0.071
Vulvovaginal discomfort	0.037	0.037037	0.037037
Vulvovaginal disorder	0.071	0	0.071
Vulvovaginal dryness	0.1	0	0.1
Vulvovaginal mycotic infection	0.071	0	0.071
Vulvovaginal pruritus	0.0194	0	0.0194175
Vulvovaginitis	0.0648	0.01	0.0648148
Weight decreased	0.232	0	0.232
Weight increased	0.227	0	0.227
Welts	0.11	0.02	0.11
Wheezing	0.1	0	0.1
White blood cell count decreased	0.13	0	0.13
White blood cells urine positive	0.02	0.02	0.02
Withdrawal syndrome	0.374	0	0.373832
Worry	0.04	0.04	0.04
Worsening of diabetes	0.00794	0.00793651	0.00793651
Wound	0.305	0.05	0.305085
Wound discharge increased	0	0	0
Wound haematoma	0	0	0
Wound haemorrhage	0.0139	0.0139373	0.0139373
Wound infection	0.069	0.069	0.069
Wound secretion	0	0	0
Xeroderma	0.06	0	0.06
Xerophthalmia	0	0	0
X-linked lymphoproliferative syndrome	0.032	0	0.032
Yawning	0.01	0	0.01

SIDER データベース中の1430の医薬品添付文書に記載された臨床成績のなかで、プラセボが使用されて有害事象が報告された被験者の割合。

ちなみに、98％の被験者にalopecia(禿げ)が報告された試験はdexrazoxaneの試験です。図は実薬の副作用の頻度です。実薬は抗がん薬の臓器障害から組織を保護する様な作用があるという事でPlaceboより有害事象の頻度が低くなることが期待されます。Placeboは結構危険かもしれません～

プラセボの有害事象

SIDERデータの集計

Frequency of Adverse Event in Placebo

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SIDERデータの集計

Frequency of Adverse Event in Placebo

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