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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
NCT ID:
NCT05461794
Description:
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
Frequency Threshold:
3
Time Frame:
All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
Study:
NCT05461794
Study Brief:
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: Tislelizumab + Sitravatinib | Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks. | 20 | None | 22 | 39 | 39 | 39 | View |
| Arm B: Sitravatinib | Sitravatinib was administered orally at a dose of 100 mg once daily. | 5 | None | 6 | 19 | 19 | 19 | View |
| Arm C: Investigator-chosen Chemotherapy (ICC) | Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle. | 19 | None | 15 | 34 | 34 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acquired tracheo-oesophageal fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 26.0 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 26.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Pneumopericardium | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Supraventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 26.0 | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Oesophageal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | meddra 26.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 26.0 | View |
| Metastases to soft tissue | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 26.0 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 26.0 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Bronchial fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 26.0 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 26.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 26.0 | View |
| Aortic valve calcification | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 26.0 | View |
| Central hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 26.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 26.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Alpha hydroxybutyrate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood creatine phosphokinase MB increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Fibrin D dimer increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| High density lipoprotein decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Red blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Urinary occult blood positive | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Urobilinogen urine increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 26.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra 26.0 | View |
| Albuminuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra 26.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra 26.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra 26.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Laryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 26.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 26.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 26.0 | View |