MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
Body temperature increased
|
Body temperature increased
|
very common, 33% - 69%
|
|
x
|
x
|
|
x
|
x
|
|
Asthenia
|
Fatigue
|
very common, 11% - 45%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
very common, 6% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
very common, 11% - 45%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neurotoxicity
|
Neurotoxicity
|
35-45%
|
|
x
|
x
|
x
|
|
x
|
x
|
Renal failure
|
Renal impairment
|
19-45%
|
|
|
|
x
|
|
x
|
x
|
Renal failure
|
rare
|
|
|
|
|
x
|
x
|
x
|
Renal impairment
|
Renal impairment
|
19-45%
|
|
|
|
x
|
|
x
|
x
|
Nausea
|
Nausea
|
very common, 5-28% - 28%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
very common, 10% - 27%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
very common, 10% - 27%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
21.8%
|
|
|
|
|
|
|
x
|
Infection
|
Infection
|
very common, 28%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral skin infection
|
Viral skin infection
|
20.8%
|
|
|
|
|
|
|
x
|
Injection site reaction
|
Injection site reaction
|
very common, 9% - 19%
|
|
x
|
x
|
x
|
x
|
|
|
Headache
|
Headache
|
very common, 7% - 22%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Decreased appetite
|
very common, 8% - 17%
|
|
x
|
x
|
|
x
|
x
|
x
|
Anorexia
|
|
|
|
|
x
|
|
|
|
Lymphopenia
|
Lymphopenia
|
very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
very common
|
|
x
|
x
|
|
x
|
x
|
x
|
Myelosuppression
|
very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
very common
|
|
x
|
x
|
x
|
x
|
|
|
Hyperhidrosis
|
3%
|
|
|
|
|
|
x
|
x
|
Vomiting
|
Vomiting
|
very common, 1-13% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
12.9%
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
very common, 6% - 12%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
Oral candidiasis
|
11.9%
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
11.9%
|
|
|
|
|
|
|
x
|
Urinary tract infection
|
Urinary tract infection
|
11.9%
|
|
|
|
|
|
|
x
|
Breath sounds abnormal
|
Breath sounds abnormal
|
very common, 4% - 11%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal chest sounds NOS
|
very common, 9%
|
|
x
|
x
|
|
x
|
|
|
Administration site reaction
|
Administration site reaction
|
11%
|
|
|
|
|
|
x
|
x
|
Inflammation
|
Inflammation
|
8.9% - 12.9%
|
|
|
|
|
|
|
x
|
Purpura
|
Purpura
|
very common, 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
very common, 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
very common, 4% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
very common, 6% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
very common, 2% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin infection
|
Skin infection
|
5.7% - 11.9%
|
|
|
|
|
|
|
x
|
Petechiae
|
Petechiae
|
common, 2% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Febrile neutropenia
|
Febrile neutropenia
|
8% - 47%
|
|
|
|
x
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
very common, 7% - 3-12%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
6% - 28.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
very common, 7% - 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
common, 5% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
common, 6% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
common, 6% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
common, 3% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
common, 3% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
4% - 6%
|
|
x
|
x
|
x
|
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
4% - 6%
|
|
x
|
x
|
x
|
|
x
|
x
|
Gastrointestinal pain
|
common
|
|
|
|
|
x
|
|
|
Oedema
|
Oedema
|
common, 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
common, 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
common, 2% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
common, 2% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
common, 6%
|
|
x
|
x
|
|
x
|
x
|
x
|
Redness
|
|
|
x
|
x
|
x
|
|
|
|
Haemorrhage
|
Haemorrhage
|
common, 6%
|
|
|
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
common, 6%
|
|
|
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
common, 3% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
common
|
|
|
|
|
x
|
x
|
x
|
Neoplasm malignant
|
Neoplasm malignant
|
common
|
|
|
|
|
x
|
|
|
Epistaxis
|
Epistaxis
|
common, 5%
|
|
x
|
x
|
x
|
x
|
|
|
Cardiac murmur
|
Cardiac murmur
|
common
|
|
|
|
|
x
|
|
|
Hypotension
|
Hypotension
|
common
|
|
|
|
|
x
|
|
|
Urticaria
|
Urticaria
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
common
|
|
|
|
|
x
|
|
|
Bone pain
|
Bone pain
|
common
|
|
|
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
common, 5% - 7%
|
|
x
|
x
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
common, 5% - 7%
|
|
x
|
x
|
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
common, 5% - 7%
|
|
x
|
x
|
|
x
|
x
|
x
|
Confusional state
|
uncommon
|
|
|
|
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
common, 5% - 7%
|
|
x
|
x
|
|
x
|
x
|
x
|
Pain of skin
|
Pain of skin
|
common
|
|
|
|
|
x
|
|
|
Mucosal inflammation
|
Mucosal inflammation
|
common
|
|
|
|
|
x
|
|
|
Bacteraemia
|
Bacteraemia
|
2%
|
|
|
|
|
|
x
|
x
|
Cellulitis
|
Cellulitis
|
2%
|
|
|
|
|
|
x
|
x
|
Ecchymosis
|
Ecchymosis
|
2%
|
|
|
|
|
|
x
|
x
|
Phlebitis
|
Phlebitis
|
uncommon, 2% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
2%
|
|
x
|
x
|
x
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
2%
|
|
|
|
|
|
x
|
x
|
Anaemia
|
Anaemia
|
very common, 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
common, 1%
|
|
|
|
|
x
|
x
|
x
|
Contusion
|
Contusion
|
1%
|
|
|
|
|
|
x
|
x
|
Flatulence
|
Flatulence
|
common, 1%
|
|
|
|
|
x
|
x
|
x
|
Localised infection
|
Localised infection
|
1%
|
|
|
|
|
|
x
|
x
|
Rales
|
Rales
|
1%
|
|
|
|
|
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
1%
|
|
|
|
|
|
x
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
uncommon
|
|
|
|
|
x
|
|
|
Cachexia
|
Cachexia
|
uncommon
|
|
|
|
|
x
|
|
|
Confusional state
|
Confusional state
|
uncommon
|
|
|
|
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
uncommon
|
|
|
|
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
uncommon
|
|
|
|
|
x
|
|
|
Paraesthesia
|
Paraesthesia
|
uncommon
|
|
|
|
|
x
|
|
|
Pharyngitis
|
Pharyngitis
|
uncommon
|
|
|
|
|
x
|
|
|
Polyneuropathy
|
Polyneuropathy
|
uncommon
|
|
|
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
uncommon
|
|
|
|
|
x
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
rare, 1%
|
|
x
|
x
|
x
|
x
|
x
|
|
Tumour lysis syndrome
|
Tumour lysis syndrome
|
rare, 1%
|
|
|
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
rare
|
|
|
|
|
x
|
|
|
Graft versus host disease
|
Graft versus host disease
|
rare
|
|
|
|
|
x
|
|
|
Cardiac failure
|
Cardiac failure
|
rare
|
|
|
|
|
x
|
|
|
Decompensation cardiac
|
rare
|
|
|
|
|
x
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
rare
|
|
|
|
x
|
x
|
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
rare
|
|
|
|
x
|
x
|
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
rare
|
|
|
|
|
x
|
|
|
Hepatic failure
|
Hepatic failure
|
rare
|
|
|
|
|
x
|
|
|
Eosinophilia
|
Hypereosinophilia
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ileus
|
Ileus
|
rare
|
|
|
|
|
x
|
|
|
Myelodysplastic syndrome
|
Myelodysplastic syndrome
|
0.03%
|
|
x
|
x
|
x
|
|
x
|
x
|
Amyloidosis
|
Amyloidosis
|
very rare
|
|
|
|
|
x
|
|
|
Blepharitis
|
Blepharitis
|
very rare
|
|
|
|
|
x
|
|
|
Cholecystitis
|
Cholecystitis
|
very rare
|
|
|
|
|
x
|
|
|
Epilepsy
|
Epilepsy
|
very rare
|
|
|
|
|
x
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
very rare
|
|
|
|
|
x
|
|
|
Alopecia
|
Alopecia
|
|
|
|
|
|
x
|
|
|
Aplastic anaemia
|
Aplastic anaemia
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Autoimmune haemolytic anaemia
|
Autoimmune haemolytic anaemia
|
|
|
|
|
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
x
|
|
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
x
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
x
|
x
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
x
|
|
|
Cyst
|
Cyst
|
|
|
|
|
|
x
|
|
|
Localised oedema
|
Localised oedema
|
|
|
|
|
|
|
x
|
x
|
Extravasation
|
Extravasation
|
|
|
|
|
x
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
x
|
x
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
x
|
x
|
Herpes virus infection
|
Herpes NOS
|
|
|
|
|
|
x
|
|
|
Herpes zoster
|
Herpes zoster
|
|
|
x
|
x
|
|
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
|
|
|
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
x
|
x
|
x
|
Infarction
|
Infarction
|
|
|
|
|
|
x
|
|
|
Renal failure acute
|
Renal failure acute
|
|
|
|
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
|
|
|
|
|
x
|
Fungal infection
|
Fungal infection
|
|
|
x
|
x
|
|
|
x
|
x
|
Neoplasm
|
Neoplasm
|
|
|
|
|
x
|
x
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
x
|
x
|
x
|
Opportunistic infection
|
Opportunistic infection
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
|
|
|
|
|
|
x
|
x
|
Polyp
|
Polyp
|
|
|
|
|
|
x
|
|
|
Pulmonary fibrosis
|
Pulmonary fibrosis
|
|
|
|
|
|
|
x
|
x
|
Respiratory tract infection
|
Respiratory tract infection
|
|
|
|
|
|
|
|
x
|
Sepsis
|
Septicemia
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
|
|
x
|
x
|
|
|
x
|
x
|
Septic shock
|
Septic shock
|
|
|
|
|
|
|
x
|
x
|
Swelling
|
Swelling
|
|
|
x
|
x
|
x
|
|
|
|
Ureteric obstruction
|
Ureteric obstruction
|
|
|
|
|
x
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
x
|
|
x
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
x
|
x
|
Peripheral sensory neuropathy
|
Peripheral sensory neuropathy
|
|
|
|
|
|
|
x
|
x
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
x
|
x
|
x
|
Interstitial lung disease
|
Interstitial lung disease
|
|
|
|
|
|
|
x
|
x
|
Metabolic acidosis
|
Metabolic acidosis
|
|
|
|
|
|
x
|
|
|
Paraparesis
|
Paraparesis
|
|
|
|
|
x
|
|
x
|
x
|
Rash macular
|
Rash macular
|
|
|
|
|
|
|
|
x
|
Dyspnoea exertional
|
Dyspnoea exertional
|
|
|
|
|
|
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
|
|
|
|
|
|
x
|
x
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
|
x
|
|
|
Neuritis
|
Peripheral motor neuropathy
|
|
|
|
|
|
|
x
|
|
Peripheral motor neuropathy
|
Peripheral motor neuropathy
|
|
|
|
|
|
|
x
|
|
Lung infiltration
|
Lung infiltration
|
|
|
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
x
|
x
|
Quadriparesis
|
Quadriparesis
|
|
|
|
|
x
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
|
|
|
|
x
|
|
|
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
x
|
x
|
Altered state of consciousness
|
Depressed level of consciousness
|
|
|
|
|
|
|
x
|
x
|
Depressed level of consciousness
|
Depressed level of consciousness
|
|
|
|
|
|
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
x
|
x
|
|
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
x
|
x
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
x
|
x
|
x
|
Culture negative
|
Culture negative
|
|
|
|
|
|
x
|
|
|
Catheter site cellulitis
|
Catheter site cellulitis
|
|
|
|
|
|
|
|
x
|
Infusion site reaction
|
Infusion site reaction
|
|
|
|
|
|
|
x
|
x
|
Urine output
|
Urine output
|
|
|
|
|
x
|
|
|
|
Death
|
Death
|
|
|
|
|
|
|
|
x
|