Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:15 AM

Ignite Modification Date: 2025-12-25 @ 10:17 PM

NCT ID: NCT02014558

Description: The total number of deaths (all causes) includes deaths reported after the time frame above.

Frequency Threshold: 5

Time Frame: From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)

Study: NCT02014558

Study Brief: Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Gilterinib 80 mg in Expansion Phase	Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	21	None	19	21	20	21	View
Gilterinib 120 mg in Expansion Phase	Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	53	None	52	66	62	66	View
Gilterinib 200 mg in Expansion Phase	Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.	82	None	92	100	97	100	View
Gilterinib 20 mg in Escalation Phase	Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	4	None	2	5	5	5	View
Gilterinib 40 mg in Escalation Phase	Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	2	None	2	3	2	3	View
Gilterinib 80 mg in Escalation Phase	Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	3	None	2	3	3	3	View
Gilterinib 120 mg in Escalation Phase	Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	3	None	1	3	3	3	View
Gilterinib 200 mg in Escalation Phase	Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	2	None	2	3	3	3	View
Gilterinib 300 mg in Escalation Phase	Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	3	None	2	3	3	3	View
Gilterinib 450 mg in Escalation Phase	Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.	3	None	2	3	3	3	View
Gilterinib 20 mg in Expansion Phase	Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.	10	None	8	12	12	12	View
Gilterinib 40 mg in Expansion Phase	Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.	13	None	12	13	12	13	View
Gilterinib 300 mg in Expansion Phase	Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.	16	None	14	17	16	17	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Disseminated intravascular coagulation	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Haemolytic anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Leukocytosis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Pancytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Supraventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Ventricular fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Ventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Diabetes insipidus	SYSTEMATIC_ASSESSMENT	Endocrine disorders	MedDRA 20	View
Conjunctival oedema	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Papilloedema	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Enteritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Enterocolitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Gastric haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Haematemesis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Haematochezia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Intestinal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Intestinal perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Large intestinal ulcer	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Upper gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Death	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Multiple organ dysfunction syndrome	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Sudden death	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Systemic inflammatory response syndrome	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Cholecystitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 20	View
Hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 20	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 20	View
Acute graft versus host disease	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Acute graft versus host disease in intestine	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Acute graft versus host disease in skin	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Clostridial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Clostridium bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Clostridium difficile colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Clostridium difficile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Corona virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Diverticulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Encephalitis viral	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Enterococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Enterocolitis infectious	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Epiglottitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Escherichia bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Escherichia sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Escherichia urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Fungaemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Gastroenteritis viral	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Hepatic infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Herpes zoster	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Periorbital infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia haemophilus	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia parainfluenzae viral	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia viral	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Post procedural cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pseudomonas infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pyelonephritis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Respiratory syncytial virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Septic shock	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Sinusitis fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Skin bacterial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Soft tissue infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Staphylococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Staphylococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection enterococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urosepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Facial bones fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Hip fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Pelvic fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Post procedural haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Road traffic accident	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Subdural haematoma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Tendon rupture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Wound complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood creatine phosphokinase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood lactate dehydrogenase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood uric acid increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Ejection fraction decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Liver function test increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Transaminases increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Troponin I increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
White blood cell count increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Diabetic ketoacidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Failure to thrive	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Tumour lysis syndrome	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Joint effusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Rhabdomyolysis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Acute myeloid leukaemia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Acute myeloid leukaemia recurrent	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Basal cell carcinoma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Central nervous system leukaemia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Leukaemia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Squamous cell carcinoma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Squamous cell carcinoma of skin	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20	View
Aphasia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Cerebral ischaemia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Cerebrovascular accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Coordination abnormal	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Haemorrhage intracranial	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Intracranial pressure increased	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Lethargy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Acute respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Acute respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Aspiration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Haemoptysis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Laryngeal mass	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Lung infiltration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pulmonary haemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Respiratory distress	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Acute febrile neutrophilic dermatosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Angioedema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Rash papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Myocarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Pericarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Acute myocardial infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Atrial fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Atrial thrombosis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Atrioventricular block second degree	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Cardiac arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Cardiac failure congestive	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Myocardial infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Lower gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Malabsorption	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Neutropenic colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Pancreatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Pancreatitis acute	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Rectal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Rectal tenesmus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Small intestinal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Anaphylactic reaction	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Chronic graft versus host disease in skin	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Graft versus host disease in skin	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Abscess limb	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Arthritis bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Bacterial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Bronchopulmonary aspergillosis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Klebsiella bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Oral infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Osteomyelitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Otitis externa	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Parainfluenzae virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Periodontitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Streptococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Streptococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Systemic candida	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Systemic mycosis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Tooth abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Tooth infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Toxic shock syndrome	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Myositis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Necrotising myositis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Osteonecrosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Loss of consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Neuralgia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Posterior reversible encephalopathy syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Presyncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Radicular pain	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Mental status changes	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Renal injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Renal tubular necrosis	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Acute promyelocytic leukaemia differentiation syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Skin lesion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Embolism	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Haematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Haemorrhage	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Phlebitis deep	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Swollen tongue	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Memory impairment	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Neuropathy peripheral	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Paraesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Peripheral sensory neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Presyncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Sciatica	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Device occlusion	SYSTEMATIC_ASSESSMENT	Product Issues	MedDRA 20	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Disorientation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Mental status changes	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Sleep disorder	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 20	View
Dysuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Pollakiuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 20	View
Nipple pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 20	View
Atelectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Dysphonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Dyspnoea exertional	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Haemoptysis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Oropharyngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pharyngeal disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Rales	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Rhinorrhoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Sinus pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Tachypnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Upper-airway cough syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Wheezing	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 20	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Blood blister	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Decubitus ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Dermatitis acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Drug eruption	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Ecchymosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Eccrine squamous syringometaplasia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Erythema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Erythema multiforme	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Pain of skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Petechiae	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Photosensitivity reaction	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Pigmentation disorder	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Rash papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Skin lesion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Swelling face	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Flushing	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Haematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Hot flush	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Pallor	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 20	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Oral candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Oral herpes	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Urinary tract infection enterococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Contusion	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Incision site pain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Periorbital haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Post procedural haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Procedural pain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Stoma site pain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Transfusion reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 20	View
Activated partial thromboplastin time prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood creatine phosphokinase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood lactate dehydrogenase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood phosphorus decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood thyroid stimulating hormone increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Blood urea increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Cardiac murmur	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Chest X-ray abnormal	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
International normalised ratio increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Liver function test increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Transaminases increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Ultrasound liver abnormal	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Volume blood increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Weight decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Weight increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
White blood cell count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 20	View
Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Fluid overload	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Fluid retention	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypercalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperphosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypochloraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypoproteinaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Hypovolaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Iron overload	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 20	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Flank pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Muscle spasms	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Musculoskeletal pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Myopathy	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Pain in jaw	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 20	View
Cognitive disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Dysaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Hyperaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Lethargy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 20	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Gingival bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Gingival pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Haemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Melaena	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Mouth haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Mouth ulceration	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Oesophagitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Oral mucosal blistering	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Oral pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Proctalgia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Rectal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Salivary hypersecretion	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Tongue coated	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Face oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Gait disturbance	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Generalised oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Local swelling	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Localised oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Nodule	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Peripheral swelling	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Serositis	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 20	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 20	View
Graft versus host disease	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Seasonal allergy	SYSTEMATIC_ASSESSMENT	Immune system disorders	MedDRA 20	View
Abscess limb	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Candida infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Gingivitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Herpes virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Herpes zoster	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Laryngitis fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Lip infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Sinus bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Ear discomfort	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	MedDRA 20	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	MedDRA 20	View
Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	MedDRA 20	View
Blepharitis	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Cataract	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Cataract nuclear	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Conjunctival haemorrhage	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Dry eye	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Eye oedema	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Eye pruritus	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Glaucoma	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Lacrimation increased	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Periorbital oedema	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Retinal exudates	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Retinal haemorrhage	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Vision blurred	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Vitreous detachment	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Vitreous floaters	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 20	View
Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Abdominal pain lower	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Abdominal pain upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Abdominal tenderness	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Aphthous ulcer	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 20	View
Clostridium difficile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Enterococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 20	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 20	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Hyperfibrinogenaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Leukocytosis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Lymphadenopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 20	View
Angina pectoris	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Atrial fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Atrial flutter	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View
Palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 20	View