MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
Leukopenia
|
Leukopenia
|
87.7%
|
|
x
|
|
Lymphopenia
|
Lymphopenia
|
82.3%
|
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
79.8% - 80.7%
|
|
x
|
x
|
Anaemia
|
Anaemia
|
75.4% - 83.3%
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
63.7%
|
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
43.4% - 80.5%
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
36% - 74%
|
|
x
|
x
|
Vomiting
|
Vomiting
|
very common, 59%
|
|
x
|
x
|
Blood bilirubin increased
|
Bilirubin total increased
|
13.2% - 44.7%
|
|
x
|
|
Blood bilirubin increased
|
|
|
|
x
|
Blood creatinine increased
|
Creatinine increased
|
7.8% - 49.5%
|
|
x
|
x
|
Blood creatinine increased
|
|
|
x
|
|
Dermatitis
|
Rash
|
21%
|
|
x
|
x
|
Rash
|
Rash
|
21%
|
|
x
|
x
|
Tachycardia
|
Tachycardia
|
common, 35%
|
|
x
|
x
|
Headache
|
Headache
|
very common, 24%
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
very common, 20%
|
|
x
|
x
|
Pruritus
|
Pruritus
|
very common, 20%
|
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
very common, 19%
|
|
x
|
x
|
Nausea
|
Nausea
|
very common
|
|
x
|
x
|
Asthenia
|
Fatigue
|
very common, 14%
|
|
x
|
x
|
Asthenia
|
|
|
x
|
|
Fatigue
|
Fatigue
|
very common, 14%
|
|
x
|
x
|
Anxiety
|
Anxiety
|
very common, 12%
|
|
x
|
x
|
Flushing
|
Flushing
|
very common, 11%
|
|
x
|
x
|
Mucosal inflammation
|
Mucosal inflammation
|
very common, 11%
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common
|
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common
|
|
x
|
x
|
Alopecia
|
Alopecia
|
common
|
|
|
x
|
Decreased appetite
|
Anorexia
|
common
|
|
x
|
x
|
Decreased appetite
|
common
|
|
|
x
|
Arthralgia
|
Arthralgia
|
common
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
common
|
|
x
|
x
|
Myalgia
|
common
|
|
x
|
x
|
Back pain
|
Back pain
|
common
|
|
x
|
x
|
Bacteraemia
|
Bacteraemia
|
common
|
|
x
|
x
|
Candida infection
|
Oral candidiasis
|
common
|
|
x
|
x
|
Candida infection
|
|
|
x
|
|
Oral candidiasis
|
Oral candidiasis
|
common
|
|
x
|
x
|
Musculoskeletal chest pain
|
Chest wall pain
|
common
|
|
|
x
|
Contusion
|
Contusion
|
common
|
|
|
x
|
Cough
|
Cough
|
common
|
|
|
x
|
Dehydration
|
Dehydration
|
common
|
|
|
x
|
Dizziness
|
Dizziness
|
common
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
common
|
|
x
|
x
|
Oedema
|
Oedema
|
common
|
|
x
|
x
|
Epistaxis
|
Epistaxis
|
common
|
|
x
|
x
|
Gingival bleeding
|
Gingival bleeding
|
common
|
|
|
x
|
Haematemesis
|
Haematemesis
|
common
|
|
|
x
|
Haematoma
|
Haematoma
|
common
|
|
|
x
|
Haematuria
|
Haematuria
|
common
|
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
common
|
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
common
|
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
common
|
|
x
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
common
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
common
|
|
x
|
x
|
Hypotension
|
Hypotension
|
common
|
|
x
|
x
|
Hypotensive
|
|
|
|
x
|
Irritability
|
Irritability
|
common
|
|
x
|
x
|
Jaundice
|
Jaundice
|
common
|
|
x
|
x
|
Multi-organ failure
|
Multi-organ failure
|
common
|
|
|
x
|
Mouth haemorrhage
|
Mouth haemorrhage
|
common
|
|
x
|
x
|
Oral mucosal petechiae
|
|
|
x
|
|
Pain
|
Pain
|
common
|
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
common
|
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
common
|
|
|
x
|
Pericardial effusion
|
Pericardial effusion
|
common
|
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
common
|
|
|
x
|
Petechiae
|
Petechiae
|
common
|
|
x
|
x
|
Pneumonia
|
Pneumonia
|
common
|
|
x
|
x
|
Prurigo
|
Prurigo
|
common
|
|
x
|
x
|
Proctalgia
|
Proctalgia
|
common
|
|
x
|
x
|
Septic shock
|
Septic shock
|
common
|
|
x
|
x
|
Stomatitis
|
Stomatitis
|
common
|
|
x
|
x
|
Mouth ulceration
|
common
|
|
|
x
|
Tremor
|
Tremor
|
common
|
|
|
x
|
Tumour lysis syndrome
|
Tumour lysis syndrome
|
common
|
|
x
|
x
|
Erythema
|
Erythema
|
common
|
|
x
|
x
|
Weight decreased
|
Weight decreased
|
common
|
|
|
x
|
Chills
|
Chills
|
common
|
|
x
|
x
|
Agitation
|
Agitation
|
common
|
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
common
|
|
|
x
|
Mouth ulceration
|
Mouth ulceration
|
common
|
|
|
x
|
Bone pain
|
Bone pain
|
common
|
|
x
|
x
|
Dry skin
|
Dry skin
|
common
|
|
|
x
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
common
|
|
|
x
|
Myalgia
|
Myalgia
|
common
|
|
x
|
x
|
Tachypnoea
|
Tachypnoea
|
common
|
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
common
|
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
common
|
|
|
x
|
Skin exfoliation
|
Skin exfoliation
|
common
|
|
|
x
|
Systemic inflammatory response syndrome
|
Systemic inflammatory response syndrome
|
common
|
|
x
|
x
|
Sepsis
|
Sepsis
|
common
|
|
x
|
x
|
Capillary leak syndrome
|
Capillary leak syndrome
|
common
|
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
common
|
|
|
x
|
Respiratory distress
|
Respiratory distress
|
common
|
|
x
|
x
|
Rash generalised
|
Rash generalised
|
common
|
|
|
x
|
Generalised erythema
|
Generalised erythema
|
common
|
|
|
x
|
Venoocclusive disease
|
Venoocclusive disease
|
common
|
|
|
x
|
Feeling abnormal
|
Feeling abnormal
|
common
|
|
|
x
|
Somnolence
|
Somnolence
|
common
|
|
x
|
x
|
Feeling hot
|
Feeling hot
|
common
|
|
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
x
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
|
|
x
|
x
|
Mental disorder
|
Mental disorder
|
|
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
x
|
Cellulitis
|
Cellulitis
|
|
|
x
|
|
Cholelithiasis
|
Cholelithiasis
|
|
|
|
x
|
Colitis
|
Colitis
|
|
|
|
x
|
Infection
|
Infection
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
|
Cyst
|
Cyst
|
|
|
x
|
x
|
Enterocolitis
|
Enterocolitis
|
|
|
|
x
|
Cardiac disorder
|
Cardiac disorder
|
|
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
|
x
|
Hypertension
|
Hypertension
|
|
|
x
|
|
Immune system disorder
|
Immune system disorder
|
|
|
x
|
x
|
Influenza
|
Influenza
|
|
|
x
|
|
Renal failure acute
|
Renal failure acute
|
|
|
|
x
|
Lethargy
|
Lethargy
|
|
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
x
|
Fungal infection
|
Fungal infection
|
|
|
x
|
|
Necrosis
|
Necrosis
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
|
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
|
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
|
|
|
x
|
Pericarditis
|
Pericarditis
|
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
|
|
x
|
|
Pneumonia mycoplasmal
|
Pneumonia mycoplasmal
|
|
|
x
|
|
Atypical pneumonia
|
Pneumonia mycoplasmal
|
|
|
x
|
|
Polyp
|
Polyp
|
|
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
x
|
x
|
Renal failure
|
Renal failure
|
|
|
|
x
|
Respiratory syncytial virus infection
|
Respiratory syncytial virus infection
|
|
|
x
|
|
Sinusitis
|
Sinusitis
|
|
|
x
|
|
Staphylococcal infection
|
Staphylococcal infection
|
|
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
x
|
x
|
Viral infection
|
Viral infection
|
|
|
|
x
|
Cholecystitis acute
|
Cholecystitis acute
|
|
|
|
x
|
Hepatocellular injury
|
Hepatocellular injury
|
|
|
|
x
|
Liver injury
|
Hepatocellular injury
|
|
|
|
x
|
Staphylococcal bacteraemia
|
Staphylococcal bacteraemia
|
|
|
x
|
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
x
|
|
Clostridium difficile colitis
|
Clostridium difficile colitis
|
|
|
|
x
|
Caecitis
|
Caecitis
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
x
|
x
|
Parainfluenzae virus infection
|
Parainfluenzae virus infection
|
|
|
x
|
|
Pneumonia fungal
|
Pneumonia fungal
|
|
|
x
|
|
Gastroenteritis adenovirus
|
Gastroenteritis adenovirus
|
|
|
x
|
|
Menorrhagia
|
Prolonged menses
|
|
|
|
x
|
Nephropathy toxic
|
Nephropathy toxic
|
|
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
x
|
x
|
Fungal sepsis
|
Fungal sepsis
|
|
|
x
|
|
Febrile neutropenia
|
Febrile neutropenia
|
|
|
x
|
|
Infestation
|
Infestation NOS
|
|
|
x
|
x
|
Escherichia sepsis
|
Escherichia sepsis
|
|
|
x
|
|
Enterococcal bacteraemia
|
Enterococcal bacteraemia
|
|
|
x
|
|
Device related infection
|
Catheter related infection
|
|
|
x
|
x
|
Escherichia bacteraemia
|
Escherichia bacteraemia
|
|
|
x
|
|
Clostridium colitis
|
Clostridium colitis
|
|
|
x
|
|
Respiratory failure
|
Respiratory failure
|
|
|
|
x
|
Death
|
Death
|
|
|
|
x
|
Deafness
|
Hearing impaired
|
|
|
|
x
|
Hearing impaired
|
Hearing impaired
|
|
|
|
x
|