MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
Infection
|
Infection
|
2% - 72%
|
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
very common, 25% - 25.2%
|
23%
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
very common
|
|
|
x
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
very common
|
|
|
x
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
14%
|
5%
|
x
|
|
|
|
Influenza
|
Influenza
|
12.9%
|
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
very common, 10%
|
8%
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
very common, 11.8% - 12%
|
7%
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
very common, 11.8% - 12%
|
7%
|
x
|
x
|
x
|
x
|
Herpes virus infection
|
Herpes NOS
|
8.71%
|
|
|
|
x
|
|
Herpes virus infection
|
common, 9%
|
8%
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
common, 8% - 9.09%
|
3.59% - 4%
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
common, 7% - 7.29%
|
6%
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
6.59% - 7%
|
5%
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
common, 8%
|
7%
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
common, 8%
|
5%
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
common, 6%
|
4%
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
5% - 5.41%
|
4%
|
x
|
|
x
|
x
|
Atrioventricular block
|
Atrioventricular block
|
common
|
|
x
|
x
|
x
|
x
|
Tinea versicolour
|
Tinea versicolour
|
common
|
|
|
x
|
|
|
Migraine
|
Migraine
|
common, 4.71% - 5%
|
1%
|
x
|
x
|
x
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
5%
|
1%
|
x
|
|
|
|
Weight decreased
|
Weight decreased
|
4.71% - 5%
|
3%
|
x
|
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
4.47% - 5%
|
3%
|
x
|
|
x
|
x
|
Lymphopenia
|
Lymphopenia
|
common, 4%
|
1%
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
common, 4%
|
1%
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
common, 3.53% - 4%
|
2%
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
common, 3%
|
1%
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
common, 3.53% - 4%
|
1%
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
Blood triglycerides increased
|
common, 3%
|
1%
|
x
|
x
|
|
x
|
Tinea infection
|
Tinea infection
|
3.76% - 4%
|
1%
|
x
|
|
x
|
x
|
Eczema
|
Eczema
|
common, 3% - 3.29%
|
2%
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
common, 2.59% - 3%
|
1%
|
x
|
x
|
x
|
x
|
Fatigue
|
|
|
|
x
|
|
|
Pruritus
|
Pruritus
|
common, 2.59% - 3%
|
1%
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
3%
|
1%
|
x
|
|
x
|
x
|
Macular oedema
|
Macular oedema
|
uncommon
|
|
x
|
x
|
x
|
x
|
Depressed mood
|
Depressed mood
|
uncommon
|
|
|
x
|
|
|
Neutrophil count decreased
|
Neutrophil count decreased
|
uncommon
|
|
|
x
|
|
|
Pneumonia
|
Pneumonia
|
uncommon, 0.471%
|
|
|
x
|
x
|
x
|
Autoimmune disorder
|
Autoimmune disorder
|
|
|
|
x
|
|
|
Mental disorder
|
Mental disorder
|
|
|
x
|
x
|
x
|
x
|
Varicella
|
Varicella
|
|
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
x
|
|
x
|
Acute disseminated encephalomyelitis
|
Acute disseminated encephalomyelitis
|
|
|
|
x
|
|
|
Eye disorder
|
Eye disorder
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
|
|
|
x
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
|
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
|
|
|
x
|
|
|
Histiocytosis haematophagic
|
Hemophagocytic lymphohistiocytosis
|
|
|
|
x
|
|
|
Lymphoma
|
Lymphoma
|
|
|
x
|
x
|
x
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
x
|
x
|
x
|
x
|
Lymphoproliferative disorder
|
Lymphoproliferative disorder
|
|
|
x
|
|
x
|
x
|
X-linked lymphoproliferative syndrome
|
Lymphoproliferative disorder
|
|
|
x
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
x
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
|
|
|
x
|
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
|
|
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
x
|
x
|
x
|
x
|
Bradyarrhythmia
|
Bradyarrhythmia
|
|
|
x
|
x
|
x
|
x
|
B-cell lymphoma
|
B-cell lymphoma
|
|
|
x
|
x
|
x
|
x
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
|
x
|
x
|
x
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
|
x
|
x
|
x
|
Atrioventricular block complete
|
Atrioventricular block complete
|
|
|
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
x
|
Liver injury
|
Liver injury
|
|
|
x
|
|
|
|
Traumatic liver injury
|
Liver injury
|
|
|
x
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
|
|
|
x
|
x
|
x
|
Atrioventricular block second degree
|
Atrioventricular block second degree
|
|
|
|
x
|
x
|
x
|
Wenckebach phenomenon
|
|
|
|
x
|
x
|
x
|
Meningoencephalitis herpetic
|
Herpes simplex encephalitis
|
|
|
|
|
x
|
x
|
Herpes simplex encephalitis
|
Herpes simplex encephalitis
|
|
|
|
|
x
|
x
|
Death
|
Found dead (cause undetermined)
|
|
|
|
x
|
x
|
x
|
Mean arterial pressure
|
Mean arterial pressure
|
|
|
|
|
x
|
x
|
Pre-existing disease
|
Pre-existing disease
|
|
|
|
x
|
x
|
x
|
Haemorrhagic stroke
|
Haemorrhagic stroke
|
|
|
x
|
|
|
|
Cerebral haemorrhage
|
Haemorrhagic stroke
|
|
|
x
|
|
|
|
Electrocardiogram PR prolongation
|
Electrocardiogram PR prolongation
|
|
|
|
x
|
x
|
x
|
Herpes zoster
|
Varicella zoster
|
|
|
|
|
x
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
x
|
|
|
Multiple sclerosis relapse
|
Multiple sclerosis relapse
|
|
|
|
|
x
|
x
|
Peripheral arterial occlusive disease
|
Peripheral arterial occlusive disease
|
|
|
x
|
x
|
x
|
x
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
|
|
x
|
x
|
x
|
x
|