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: 2025-12-24 @ 10:12 PM

Ignite Modification Date: 2025-12-25 @ 7:48 PM

NCT ID: NCT02752035

Description: ACM: All randomized participants. AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).

Frequency Threshold: 5

Time Frame: All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)

Study: NCT02752035

Study Brief: A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

Event Groups(If Any):

Event Groups

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

Randomized Cohort: Gilteritinib + AZA	Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.	70	None	81	88	87	88	View
Randomized Cohort: AZA	Participants received 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.	49	None	34	54	46	54	View
Randomized Cohort: Gilteritinib	Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.	22	None	20	22	22	22	View
Safety Cohort: Gilteritinib + Azacitidine (AZA)	Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.	14	None	14	15	15	15	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Bone marrow failure	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Disseminated intravascular coagulation	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Febrile bone marrow aplasia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Pancytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Acute coronary syndrome	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Atrial fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Atrial flutter	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Cardiac arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Cardiovascular insufficiency	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Pericarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Torsade de pointes	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Ventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Antithrombin III deficiency	SYSTEMATIC_ASSESSMENT	Congenital, familial and genetic disorders	MedDRA v23	View
Retinitis pigmentosa	SYSTEMATIC_ASSESSMENT	Congenital, familial and genetic disorders	MedDRA v23	View
Vertigo positional	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	MedDRA v23	View
Blindness	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA v23	View
Acquired macroglossia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Anal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Enterocolitis haemorrhagic	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Gastric haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Gingival bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Haemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Intestinal perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Lower gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Melaena	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Pancreatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
General physical health deterioration	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Generalised oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Multiple organ dysfunction syndrome	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Organ failure	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Sudden death	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Bile duct stone	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Cholangitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Cholecystitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Cholecystitis acute	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Hepatic function abnormal	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Hepatitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Hepatotoxicity	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Abdominal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Bacillus bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Bacterial urethritis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Brain abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Bronchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Bronchopulmonary aspergillosis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
COVID-19	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
COVID-19 pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Clostridium bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Clostridium difficile colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Clostridium difficile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Endocarditis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Enterococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Erysipelas	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Escherichia bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Escherichia urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Fungaemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Genital infection fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Haematoma infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Impetigo	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Klebsiella bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Klebsiella sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Lower respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Lower respiratory tract infection fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Orchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Periodontitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Peritonitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumocystis jirovecii pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumonia fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumonia viral	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pseudomembranous colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pseudomonal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pseudomonal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pulmonary sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pyelonephritis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Septic embolus	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Septic shock	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Soft tissue infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Staphylococcal abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Staphylococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Systemic candida	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Tooth abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Urinary tract infection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Urinary tract infection enterococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Urosepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Ankle fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Femur fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Lumbar vertebral fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Sternal fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Subdural haematoma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Transfusion reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Blood creatine phosphokinase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
C-reactive protein increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Ejection fraction decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Staphylococcus test positive	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Adult failure to thrive	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Lactic acidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Tumour lysis syndrome	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Fasciitis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Haemarthrosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Joint effusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Muscle haemorrhage	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Rhabdomyolysis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Acute myeloid leukaemia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Adenocarcinoma of colon	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Central nervous system leukaemia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Chloroma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Colorectal cancer	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Differentiation syndrome	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Squamous cell carcinoma of skin	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v23	View
Central nervous system lesion	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Cerebral haemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Cerebrovascular accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Cluster headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Epilepsy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Intracranial haematoma	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Normal pressure hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Hydronephrosis	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Nephritis	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Prerenal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Acute pulmonary oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Acute respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Aspiration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Bronchiectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Bronchopneumopathy	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Lung disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Organising pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pneumonia aspiration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pulmonary haemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Acute febrile neutrophilic dermatosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Angioedema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Neutrophilic dermatosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Skin lesion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Hypertensive crisis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Hypovolaemic shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Peripheral ischaemia	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Pancreatitis acute	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Hepatitis acute	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Suicidal ideation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Disseminated intravascular coagulation	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Leukopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA v23	View
Cardiac dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Extrasystoles	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA v23	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	MedDRA v23	View
Blepharitis	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA v23	View
Conjunctival haemorrhage	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA v23	View
Meibomian gland dysfunction	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA v23	View
Ocular hyperaemia	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA v23	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Anal incontinence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Injection site erythema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Injection site reaction	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Medical device pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Medical device site reaction	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Peripheral swelling	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Physical deconditioning	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Hepatic function abnormal	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Hepatocellular injury	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA v23	View
Acinetobacter bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
COVID-19	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Conjunctivitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Oral candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Oral herpes	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Periodontitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Pneumonia fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Rhinitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Staphylococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Tongue fungal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Urinary tract infection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Allergic transfusion reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Contusion	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Skin laceration	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Transfusion reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA v23	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood creatine phosphokinase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood glucose increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood magnesium decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Blood urea increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Ejection fraction decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Gamma-glutamyltransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Liver function test abnormal	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Oxygen saturation decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Transaminases increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Urine output decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Weight decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
White blood cell count decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA v23	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Tumour lysis syndrome	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Bursitis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Muscle spasms	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Musculoskeletal pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Myopathy	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Rotator cuff syndrome	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA v23	View
Ataxia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Oropharyngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Tachypnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Decubitus ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Drug eruption	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Erythema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Panniculitis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Petechiae	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Skin lesion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Urticaria	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA v23	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Haematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Phlebitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Vasculitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA v23	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Gingival bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Haemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Mouth haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Mouth ulceration	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Oral pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA v23	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Catheter site haematoma	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Catheter site haemorrhage	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Chest pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Discomfort	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Generalised oedema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Infusion site extravasation	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA v23	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Enterobacter bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Enterococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Escherichia urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Fungal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Herpes zoster	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Hordeolum	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Lip infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Liver abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA v23	View
Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Fluid overload	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Gout	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA v23	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Hypoaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Neuropathy peripheral	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA v23	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA v23	View
Azotaemia	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Dysuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Oliguria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA v23	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View
Dysphonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA v23	View