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 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
NCT ID:
NCT02775903
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality was assessed from the participants first dose to their study completion (up to approximately 66 months) SAEs and Other AEs were assessed from first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine (up to approximately 66 months)
Study:
NCT02775903
Study Brief:
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MDS: Azacitidine + Durvalumab | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 22 | None | 34 | 38 | 38 | 38 | View |
| MDS: Azacitidine Alone | Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 27 | None | 29 | 41 | 40 | 41 | View |
| AML: Azacitidine + Durvalumab | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 48 | None | 56 | 64 | 63 | 64 | View |
| AML: Azacitidine Alone | Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met. | 42 | None | 45 | 62 | 60 | 62 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Cytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Oesophageal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Perineal cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 21.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Acute abdomen | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Autoimmune colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Mouth haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Granuloma | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site vesicles | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.1 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.1 | View |
| Aspergillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Atypical pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Corona virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Injection site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Lower respiratory tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Metapneumovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Micrococcus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Progressive multifocal leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pseudomonal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pulmonary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Rectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Serratia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Staphylococcal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Streptococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Superinfection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Synovial rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Traumatic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Traumatic intracranial haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Muscle haemorrhage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | View |
| Transformation to acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | View |
| Tumour associated fever | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Intraventricular haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 21.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 21.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Female genital tract fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 21.1 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 21.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Acute febrile neutrophilic dermatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Panniculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Pemphigoid | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Toxic skin eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Hypovolaemic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Peripheral artery thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Bone marrow failure | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 21.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 21.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Mouth haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 21.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 21.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 21.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Pharyngeal erythema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 21.1 | View |