Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT03139604
Description: None
Frequency Threshold: 5
Time Frame: 30 days after last dose approximately up to 24 months
Study: NCT03139604
Study Brief: GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Itacitinib Plus Corticosteroids Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease. 69 None 133 215 207 215 View
Placebo Plus Corticosteroids Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease. 69 None 131 216 206 216 View
Total Total 138 None 264 431 413 431 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Acute graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Extradural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Graft versus host disease in lung SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypofibrinogenaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Limbic encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Microangiopathic haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Microangiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Mucormycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Acute graft versus host disease in intestine SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Acute myeloid leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Adenoviral hepatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Amyotrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Anal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Bartter's syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 22 View
Blast cell crisis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Bullous oedema of the bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Clostridium test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cytomegalovirus colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Diabetic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Disseminated aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Electrocardiogram T wave abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Enterococcus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Epstein-Barr virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Fungal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrointestinal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Klebsiella test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Meningoencephalitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Pseudomonal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Rotavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Sinusitis aspergillus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Sinusitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Spinal subdural haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Streptococcal urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Transplant dysfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Transplant failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Venoocclusive liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Obliterative bronchiolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Ophthalmic herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pneumatosis intestinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia necrotising SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Post transplant lymphoproliferative disorder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Steroid diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Substance-induced psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
T-cell lymphoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Toxic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Toxoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Varicella zoster virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Viral diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Viral haemorrhagic cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Nasal cavity cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Adenovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Bicytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Campylobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cerebral toxoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Chronic lymphocytic leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cytomegalovirus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cytomegalovirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Enterovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Epstein-Barr virus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastroenteritis rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Haemoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Large intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Lower respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cytomegalovirus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Cytomegalovirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Epstein-Barr virus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View