TABLE 5.

Same ADRs among two DNA methylation inhibitors.

System organ classes	ADRs	Signal N
Blood and lymphatic system disorders	Neutropenia, Cytopenia, Anaemia, Bone marrow failure, Agranulocytosis, Splenomegaly, Thrombocytosis, Myelosuppression, Thrombocytopenia, Pancytopenia, Haematotoxicity, Granulocytopenia, Febrile neutropenia, Leukopenia, Leukocytosis	15
Cardiac disorders	Cardiac failure congestive, Cardiac arrest, Acute myocardial infarction, Atrial fibrillation, Pericardial effusion, Tachycardia, Supraventricular tachycardia, Cardiac failure, Myocardial infarction	9
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders	Colitis, Gingival bleeding, Diarrhoea, Abdominal discomfort, Stomatitis, Nausea, Abdominal pain, Gastrointestinal haemorrhage, Abdominal distension, Abdominal pain upper, Dyspepsia, Constipation, Dysphagia, Mouth ulceration, Melaena, Vomiting	16
General disorders and administration site conditions	Pain, Drug ineffective, Multiple organ dysfunction syndrome, Chest pain, Disease progression, Chills, General physical health deterioration, Fatigue, Oedema peripheral, Mucosal inflammation, Pyrexia, Death, Malaise, Therapy non-responder, Treatment failure, Asthenia, Condition aggravated	17
Hepatobiliary disorders	Hepatic function abnormal, Hyperbilirubinaemia	2
Immune system disorders	Hypersensitivity, Graft versus host disease	2
Infections and infestations	Bacteraemia, Urinary tract infection, Bacterial infection, Cellulitis, Sepsis, Bronchopulmonary aspergillosis, Aspergillus infection, Fungal infection, Upper respiratory tract infection, Pneumonia, Infection, Neutropenic sepsis, Septic shock, Staphylococcal infection, Pneumonia fungal, Diverticulitis	16
Injury, poisoning and procedural complications	Product use in unapproved indication, Subdural haematoma, Contusion, Off label use, Toxicity to various agents, Product use issue, Fall	7
Investigations	Blood bilirubin increased, Full blood count abnormal, Aspartate aminotransferase increased, White blood cell count increased, Alanine aminotransferase increased, Platelet count decreased, Weight decreased, Red blood cell count decreased, C-reactive protein increased, Neutrophil count decreased, White blood cell count decreased, Blood creatinine increased, Haemoglobin decreased	13
Metabolism and nutrition disorders	Hyponatraemia, Hyperkalaemia, Hyperglycaemia, Dehydration, Decreased appetite, Tumour lysis syndrome, Hypokalaemia	7
Musculoskeletal and connective tissue disorders	Muscle spasms, Arthralgia, Pain in extremity, Muscular weakness, Musculoskeletal pain, Back pain, Bone pain, Myalgia	8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Leukaemia recurrent, Myelodysplastic syndrome, Acute myeloid leukaemia recurrent, Acute myeloid leukaemia, Leukaemia, Malignant neoplasm progression, Neoplasm progression	7
Nervous system disorders	Cerebrovascular accident, Haemorrhage intracranial, Cerebral haemorrhage, Seizure, Somnolence, Headache, Syncope, Neuropathy peripheral, Dizziness	10
Pregnancy, puerperium and perinatal conditions
Product issues
Psychiatric disorders	Insomnia, Mental status changes, Anxiety, Confusional state	4
Renal and urinary disorders	Dysuria, Haematuria, Acute kidney injury, Renal impairment, Renal failure, Urinary retention	6
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders	Cough, Interstitial lung disease, Pneumonitis, Lung infiltration, Acute respiratory distress syndrome, Respiratory distress, Pulmonary oedema, Oropharyngeal pain, Pleural effusion, Respiratory failure, Dyspnoea, Hypoxia, Organising pneumonia, Acute respiratory failure, Pulmonary embolism, Epistaxis, Haemoptysis	17
Skin and subcutaneous tissue disorders	Rash maculo-papular, Alopecia, Petechiae, Ecchymosis, Erythema, Rash, Urticaria, Acute febrile neutrophilic dermatosis, Pruritus, Hyperhidrosis	10
Social circumstances
Surgical and medical procedures	Hospitalisation	1
Vascular disorders	Hypotension, Phlebitis, Haematoma, Deep vein thrombosis, Haemorrhage, Hypertension	6