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: 2025-12-25 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT03764293
Description: None
Frequency Threshold: 5
Time Frame: Up to approximately 3 years
Study: NCT03764293
Study Brief: A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Camrelizumab+Rivoceranib Arm Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously. Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days. 34 None 114 272 268 272 View
Sorafenib Arm Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously. 17 None 49 269 262 269 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastriculcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Immune-mediated pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Urethral neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Biloma SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Immune-mediated encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myasthenic syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations None View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colonic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchial haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Immune-mediated myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Reactive capillary endothelial proliferation SYSTEMATIC_ASSESSMENT Immune system disorders None View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nerve injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteonecrosis of jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Affective disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations None View
Total bile acids increased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary occult blood positive SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Reactive capillary endothelial proliferation SYSTEMATIC_ASSESSMENT Immune system disorders None View