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 @ 2:32 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT02907359
Description: All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment. Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen. As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.
Frequency Threshold: 5
Time Frame: From first dose through end of study (up to approximately 46.6 months)
Study: NCT02907359
Study Brief: Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Guadecitabine Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles). 237 None 216 270 266 270 View
Treatment Choice Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles. 122 None 65 122 107 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Febrile Bone Marrow Aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukostasis Syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Bone Marrow Failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Gastrointestinal Arteriovenous Malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 21.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Chronic Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Enterovesical Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastric Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal Vascular Malformation Haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Intestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Mouth Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Megacolon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Retroperitoneal Haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Multiple Organ Dysfunction Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Anaphylactic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchopulmonary Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cellulitis Orbital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Chronic Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Corynebacterium Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pseudomonal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Abscess Jaw SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Anorectal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Brain Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterocolitis Infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Haematoma Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Metapneumovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Mucormycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Necrotising Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Necrotising Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Periorbital Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pseudomembranous Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis Fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Streptococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary Tract Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulval Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Wound Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Candida Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nocardiosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Subarachnoid Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Acute Haemolytic Transfusion Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Joint Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Post Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Subdural Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Subdural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Toxicity To Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Lumbar Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Transfusion Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
C-Reactive Protein Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
General Physical Condition Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Troponin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Tumour Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Fistula Inflammation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Joint Effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Synovial Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteoporotic Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Metastases To Central Nervous System SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Transitional Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Central Nervous System Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Tumour Associated Fever SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Haemorrhage Intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Central Nervous System Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Intracranial Haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Loss Of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Organic Brain Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Urinary Tract Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleuritic Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bronchopneumopathy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Choking SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary Mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acute Febrile Neutrophilic Dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Aortic Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Internal Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Shock Haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Splenic Infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Lower Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Small Intestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Upper Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Aphthous Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Systemic Inflammatory Response Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Anal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Corona Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Transfusion Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View