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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT05405166
Description: Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
Frequency Threshold: 5
Time Frame: Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Study: NCT05405166
Study Brief: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isa-IV + Pd Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first. 49 None 127 264 241 264 View
Isa-SC + Pd Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first. 50 None 139 263 234 263 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Bullous Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Covid-19 Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Campylobacter Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Campylobacter Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Coronavirus Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cryptococcal Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cryptosporidiosis Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cytomegalovirus Chorioretinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Dengue Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Diarrhoea Infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Disseminated Cryptococcosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Gastroenteritis Escherichia Coli SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Gastroenteritis Salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Haematological Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Infective Exacerbation Of Asthma SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Infective Exacerbation Of Chronic Obstructive Airways Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Listeria Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Liver Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Lower Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Ludwig Angina SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Meningitis Cryptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Meningitis Listeria SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Meningococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Metapneumovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Metapneumovirus Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Neutropenic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Parainfluenzae Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pertussis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumocystis Jirovecii Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Adenoviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Parainfluenzae Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Respiratory Syncytial Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Syncytial Virus Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Syncytial Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Rhinovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Staphylococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Staphylococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Upper Respiratory Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Wound Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Adrenal Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Invasive Breast Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Leptomeningeal Myelomatosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Papillary Thyroid Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Plasma Cell Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Plasma Cell Myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Squamous Cell Carcinoma Of Skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Adrenal Disorder SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypercalcaemia Of Malignancy SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Drug Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Cluster Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Haemorrhagic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Peripheral Sensorimotor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Posterior Reversible Encephalopathy Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Putamen Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Spinal Cord Compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Toxic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Trigeminal Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Vocal Cord Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Cataract Nuclear SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Arteriosclerosis Coronary Artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pulmonary Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Diverticular Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Oesophageal Ulcer Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Upper Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hepatitis Fulminant SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Ischaemic Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Scar Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Haematoma Muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Pathological Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Blood Potassium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Craniocerebral Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Pelvic Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Toxicity To Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View