Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
Thrombocytopenia
|
very common, 3.2% - 69.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
very common, 2.3% - 69.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
very common, 0.98% - 51.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
20.7% - 29.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
15.2% - 29.5%
|
|
|
|
x
|
|
|
|
x
|
x
|
Neutropenia
|
very common, 2.7% - 65.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rigors
|
10.9% - 25.5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
very common, 0% - 70.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ecchymosis
|
very common, 15.2% - 30.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorexia
|
very common, 6.52% - 20.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
very common, 3.26% - 22.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
very common, 5.43% - 16.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
very common, 14.1% - 36.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
very common, 5.43% - 18.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
very common, 1.96% - 35.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
very common, 10.9% - 21.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
very common, 0.98% - 48.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
10.9% - 18.6%
|
|
|
|
x
|
|
|
|
x
|
x
|
Nasopharyngitis
|
very common, 3.26% - 14.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
7.61% - 18.6%
|
|
|
|
|
|
|
|
x
|
x
|
Epistaxis
|
9.78% - 16.4%
|
|
|
|
x
|
|
|
|
x
|
x
|
Pain in extremity
|
5.43% - 20%
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal pain
|
very common, 0% - 15.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pitting edema
|
9.78% - 14.5%
|
|
|
|
|
|
|
|
x
|
x
|
Dyspnoea
|
very common, 1.96% - 29.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin lesion
|
8.7% - 14.5%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
Pallor
|
7.61% - 15.5%
|
|
|
|
|
|
|
|
x
|
x
|
Pneumonia
|
very common, 2.5% - 10.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
8.7% - 12.7%
|
|
|
|
|
|
|
|
x
|
x
|
Febrile neutropenia
|
very common, 2.7% - 16.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Contusion
|
common, 9.78% - 18.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
common — 0% - 14.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
7.61% - 11.8%
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac murmur
|
8.7% - 10%
|
|
|
|
|
|
|
|
x
|
x
|
Petechiae
|
very common, 0% - 23.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rales
|
8.64% - 10.5%
|
|
|
|
|
|
|
|
x
|
x
|
Fatigue aggravated
|
4.35% - 12.7%
|
|
|
|
|
|
|
|
x
|
x
|
Pruritus
|
common — 0% - 12.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Productive cough
|
4.35% - 11.4%
|
|
|
|
|
|
|
|
x
|
x
|
Constipation
|
very common, 0% - 50.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
common, 7.61% - 20%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
Tachycardia
|
6.52% - 8.64%
|
|
|
|
|
|
|
|
x
|
x
|
Pain
|
3.26% - 10.9%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
very common, 0% - 54.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
3.26% - 10.5%
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal tenderness
|
1.09% - 11.8%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pleural effusion
|
6.36% - 6.52%
|
|
|
|
|
|
|
|
x
|
x
|
Lymphadenopathy
|
3.26% - 9.55%
|
|
|
|
|
|
|
|
x
|
x
|
Peripheral swelling
|
5.43% - 7.27%
|
|
|
|
|
|
|
|
x
|
x
|
Sweating increased
|
2.17% - 10.5%
|
|
|
|
|
|
|
|
x
|
x
|
Cellulitis
|
4.35% - 8.18%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
2.17% - 10%
|
|
|
|
|
|
|
|
x
|
x
|
Night sweats
|
3.26% - 8.64%
|
|
|
|
|
|
|
|
x
|
x
|
Syncope
|
5.43% - 5.91%
|
|
|
|
|
|
|
|
x
|
x
|
Oral mucosal petechiae
|
3.26% - 7.73%
|
|
|
|
|
|
|
|
x
|
x
|
Anaemia NOS aggravated
|
5.43% - 5.45%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
common, 5.43% - 9.09%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
Wheezing
|
2.17% - 8.64%
|
|
|
|
|
|
|
|
x
|
x
|
Dysuria
|
2.17% - 8.18%
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal distension
|
4.35% - 5.91%
|
|
|
|
|
|
|
|
x
|
x
|
Alopecia
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Confusional state
|
common
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
Conjunctival haemorrhage
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Eye haemorrhage
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Gastrointestinal haemorrhage
|
common, 0.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingival bleeding
|
common, 4.35% - 9.55%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematoma
|
common, 0% - 8.64%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Hypokalaemia
|
common, 1.71% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
common, 2.17% - 6.82%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inflammation
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Musculoskeletal pain
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Nodule
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Pancytopenia
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Purpura
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Sinusitis
|
common, 3.26% - 5%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
Stomatitis
|
common, 0% - 7.73%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
common, 0% - 8.57%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
common, 0% - 15.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage intracranial
|
common, 0.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash macular
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Malaise
|
common, 1.09% - 10.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
common, 2.17% - 15.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea exertional
|
common, 0% - 16.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhoidal haemorrhage
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Induration
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
Neutropenic sepsis
|
common, 0.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Cramp muscle
|
3.26% - 5.91%
|
|
|
|
|
|
|
|
x
|
x
|
Postnasal drip
|
3.26% - 5.91%
|
|
|
|
|
|
|
|
x
|
x
|
Respiratory sounds decreased
|
1.09% - 7.73%
|
|
|
|
|
|
|
|
x
|
x
|
Dyspepsia
|
common, 0% - 6.82%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
common, 0% - 16.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
common, 0% - 12.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
common, 0% - 10.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea exacerbated
|
3.26% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Rhonchi
|
2.17% - 5.91%
|
|
|
|
|
|
|
|
x
|
x
|
Haemorrhoids
|
1.09% - 6.82%
|
|
|
|
|
|
|
|
x
|
x
|
Hypertension
|
common, 1.14% - 8.57%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Atelectasis
|
2.17% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Dysphagia
|
2.17% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Tongue ulceration
|
2.17% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Post procedural pain
|
2.17% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Urticaria
|
1.09% - 5.91%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Post procedural haemorrhage
|
1.09% - 5.91%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Transfusion reaction
|
0% - 6.82%
|
|
|
|
x
|
|
|
|
x
|
x
|
Injection site pruritus
|
0% - 6.82%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Nasal congestion
|
1.09% - 5.45%
|
|
|
|
|
|
|
|
x
|
x
|
Anxiety
|
common, 0% - 13.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
1.09% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
Mouth haemorrhage
|
1.09% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin nodule
|
1.09% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
1.09% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pharyngolaryngeal pain
|
common, 0% - 6.29%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Loose stools
|
0% - 5.45%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Chest wall pain
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site granuloma
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site swelling
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site pigmentation changes
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
common, 0.98% - 6.29%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
common, 0% - 7.73%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
common, 0% - 5.71%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Injection site reaction
|
very common, 0% - 29.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
uncommon, 0.25%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tumour lysis syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Acute febrile neutrophilic dermatosis
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
|
|
Injection site necrosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Interstitial lung disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal tubular acidosis
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Refractory anaemia with an excess of blasts
|
|
|
|
|
|
|
x
|
x
|
|
|
Atrial fibrillation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Bacterial infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blastomycosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
|
|
|
|
x
|
|
|
|
|
|
Congestive cardiomyopathy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Neck pain
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cholecystitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Coma
|
|
|
|
|
|
|
|
x
|
|
|
Infection
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cyst
|
|
|
|
|
x
|
|
|
|
|
|
Dehydration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Diverticulitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Haemoptysis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Coma hepatic
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Neoplasm
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyp
|
|
|
|
|
x
|
|
|
|
|
|
Prurigo
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis streptococcal
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Septic shock
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Splenomegaly
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Staphylococcal infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Toxoplasmosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic failure
|
|
|
|
x
|
|
|
|
|
|
|
Pyoderma gangrenosum
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Bone marrow depression
|
|
|
|
|
|
|
|
|
x
|
x
|
Muscular weakness
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
very common, 0% - 22.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Staphylococcal bacteraemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatal outcomes
|
|
|
|
x
|
|
|
|
|
|
|
Injection site infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Loin pain
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Lung infiltration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin induration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Systemic inflammatory response syndrome
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Perirectal abscess
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Refractory anemia with excess blasts in transformation
|
|
|
|
|
|
|
x
|
x
|
|
|
Respiratory distress
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pneumonia klebsiella
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site dermatitis
|
0% - 5.71%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Injection site bruising
|
0% - 14.1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injection site induration
|
0% - 5.14%
|
|
|
|
|
x
|
x
|
x
|
|
|
Injection site haematoma
|
0% - 6.29%
|
|
|
|
|
x
|
x
|
x
|
|
|
Bone pain aggravated
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Abscess limb
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardio-respiratory arrest
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Klebsiella sepsis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Infestation NOS
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood and lymphatic system disorders
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site erythema
|
very common, 0% - 42.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
General physical health deterioration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Catheter site haemorrhage
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Catheter site erythema
|
|
|
|
|
x
|
|
|
|
|
|
Leukaemia cutis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Infusion site reactions
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Cerebral haemorrhage
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
Metastatic disease
|
|
|
x
|
x
|
x
|
|
|
|
|
|