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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
NCT ID:
NCT04732494
Description:
None
Frequency Threshold:
3
Time Frame:
All-cause mortality is reported from randomization through the end of study; up to 30 months. AEs are reported from first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
Study:
NCT04732494
Study Brief:
Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic 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 Plus Ociperlimab | Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 39 | None | 27 | 62 | 57 | 62 | View |
| Arm B: Tislelizumab Plus Placebo | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 36 | None | 28 | 63 | 54 | 63 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 25.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Immune-mediated myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 25.0 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 25.0 | View |
| Secondary adrenocortical insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 25.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Oesophageal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Oesophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Oesophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 25.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra 25.0 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 25.0 | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra 25.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra 25.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra 25.0 | View |
| Acquired tracheo-oesophageal fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Immune-mediated lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Immune-mediated dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Hypovolaemic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 25.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 25.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra 25.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra 25.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 25.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | meddra 25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood creatine phosphokinase MB increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood thyroid stimulating hormone decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Electrocardiogram high voltage | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyperchloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 25.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 25.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 25.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra 25.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 25.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra 25.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra 25.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra 25.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra 25.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | meddra 25.0 | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra 25.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |
| Tri-iodothyronine decreased | SYSTEMATIC_ASSESSMENT | Investigations | meddra 25.0 | View |