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 @ 2:49 PM
Ignite Modification Date:
2025-12-25 @ 1:17 PM
NCT ID:
NCT03662659
Description:
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Frequency Threshold:
5
Time Frame:
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 63 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 63 months).
Study:
NCT03662659
Study Brief:
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BMS986213 + Chemotherapy | BMS986213 Q3W + Investigator Choice (IC) Chemotherapy | 122 | None | 110 | 136 | 130 | 136 | View |
| Nivolumab + Chemotherapy | Nivolumab Q3W + Investigator Choice (IC) Chemotherapy | 118 | None | 100 | 135 | 133 | 135 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 26.1 | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 26.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Nephropathy toxic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Renal tubular necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Immune-mediated lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Organising pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Pelvic venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Vestibular disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Glucocorticoid deficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Immune-mediated hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Lymphocytic hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Blindness unilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Enterocolitis haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrointestinal inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Immune-mediated enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oesophageal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oesophageal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oesophageal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oesophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Small intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Gallbladder obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hepatitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hepatobiliary disease | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Immune-mediated hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Contrast media reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Adrenalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Cholangitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Enterobacter sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Large intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Suspected COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| General physical condition abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Abdominal wall neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Bladder transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Infected neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Lymphangiosis carcinomatosa | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Metastases to meninges | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Metastases to skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Metastatic gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Neuroendocrine tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Ovarian neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Tumour perforation | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Axonal neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Encephalitis autoimmune | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Guillain-Barre syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Immune thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Arteriospasm coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Cold dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |