Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:53 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT04338269
Description: The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.
Frequency Threshold: 5
Time Frame: All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.
Study: NCT04338269
Study Brief: A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atezolizumab + Cabozantinib Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator. 89 None 126 262 255 262 View
Cabozantinib (Control) Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator. 87 None 84 256 251 256 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Blood loss anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 25. View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 25. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Gastrointestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 25. View
Haemophagocytic lymphohistiocytosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 25. View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Aspergilloma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Fournier's gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Human herpesvirus 6 encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Spinal cord infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Suspected COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 25. View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Haematoma muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Immune-mediated arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 25. View
Enchondromatosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 25. View
Cerebrovascular stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Immune-mediated encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Radicular pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA version 25. View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 25. View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Renal artery stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 25. View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 25. View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Toxic skin eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25. View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25. View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25. View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25. View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 25. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 25. View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 25. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25. View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 25. View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 25. View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 25. View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 25. View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 25. View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Hair colour changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 25. View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 25. View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 25. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 25. View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 25. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 25. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 25. View