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 @ 10:13 PM

Ignite Modification Date: 2025-12-25 @ 7:48 PM

NCT ID: NCT00678535

Description: An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.

Frequency Threshold: 5

Time Frame: Time from first dose up to 30 days after the last dose of study treatment.

Study: NCT00678535

Study Brief: Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.	None	None	239	446	441	446	View
Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.	None	None	194	436	429	436	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	None	Blood and lymphatic system disorders	None	View
Neutropenia	None	Blood and lymphatic system disorders	None	View
Febrile neutropenia	None	Blood and lymphatic system disorders	None	View
Leukopenia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Disseminated intravascular coagulation	None	Blood and lymphatic system disorders	None	View
Granulocytopenia	None	Blood and lymphatic system disorders	None	View
Acute myocardial infarction	None	Cardiac disorders	None	View
Cardiac arrest	None	Cardiac disorders	None	View
Myocardial infarction	None	Cardiac disorders	None	View
Atrial fibrillation	None	Cardiac disorders	None	View
Cardio-respiratory arrest	None	Cardiac disorders	None	View
Myocardial ischaemia	None	Cardiac disorders	None	View
Acute coronary syndrome	None	Cardiac disorders	None	View
Angina pectoris	None	Cardiac disorders	None	View
Atrial flutter	None	Cardiac disorders	None	View
Cardiac failure	None	Cardiac disorders	None	View
Cardiopulmonary failure	None	Cardiac disorders	None	View
Intracardiac thrombus	None	Cardiac disorders	None	View
Sick sinus syndrome	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Ventricular extrasystoles	None	Cardiac disorders	None	View
Cardiomyopathy	None	Cardiac disorders	None	View
Sinus tachycardia	None	Cardiac disorders	None	View
Pyloric stenosis	None	Congenital, familial and genetic disorders	None	View
Auricular perichondritis	None	Ear and labyrinth disorders	None	View
Vertigo	None	Ear and labyrinth disorders	None	View
Adrenal insufficiency	None	Endocrine disorders	None	View
Hyperthyroidism	None	Endocrine disorders	None	View
Ocular icterus	None	Eye disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Ascites	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Ileus	None	Gastrointestinal disorders	None	View
Abdominal pain upper	None	Gastrointestinal disorders	None	View
Intestinal obstruction	None	Gastrointestinal disorders	None	View
Obstruction gastric	None	Gastrointestinal disorders	None	View
Subileus	None	Gastrointestinal disorders	None	View
Melaena	None	Gastrointestinal disorders	None	View
Upper gastrointestinal haemorrhage	None	Gastrointestinal disorders	None	View
Abdominal distension	None	Gastrointestinal disorders	None	View
Abdominal pain lower	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Gastric perforation	None	Gastrointestinal disorders	None	View
Gastric stenosis	None	Gastrointestinal disorders	None	View
Gastrointestinal obstruction	None	Gastrointestinal disorders	None	View
Intestinal perforation	None	Gastrointestinal disorders	None	View
Oesophageal perforation	None	Gastrointestinal disorders	None	View
Pneumatosis intestinalis	None	Gastrointestinal disorders	None	View
Colonic polyp	None	Gastrointestinal disorders	None	View
Erosive oesophagitis	None	Gastrointestinal disorders	None	View
Gastric haemorrhage	None	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	None	Gastrointestinal disorders	None	View
Gastrointestinal stenosis	None	Gastrointestinal disorders	None	View
Haematemesis	None	Gastrointestinal disorders	None	View
Haemorrhoids	None	Gastrointestinal disorders	None	View
Ileus paralytic	None	Gastrointestinal disorders	None	View
Inguinal hernia	None	Gastrointestinal disorders	None	View
Mechanical ileus	None	Gastrointestinal disorders	None	View
Small intestinal obstruction	None	Gastrointestinal disorders	None	View
Stomatitis	None	Gastrointestinal disorders	None	View
General physical health deterioration	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Disease progression	None	General disorders	None	View
Asthenia	None	General disorders	None	View
Mucosal inflammation	None	General disorders	None	View
Performance status decreased	None	General disorders	None	View
Device dislocation	None	General disorders	None	View
Non-cardiac chest pain	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Device occlusion	None	General disorders	None	View
Stent malfunction	None	General disorders	None	View
Sudden death	None	General disorders	None	View
Chest discomfort	None	General disorders	None	View
Death	None	General disorders	None	View
Multi-organ failure	None	General disorders	None	View
Pain	None	General disorders	None	View
Jaundice cholestatic	None	Hepatobiliary disorders	None	View
Bile duct stenosis	None	Hepatobiliary disorders	None	View
Cholecystitis	None	Hepatobiliary disorders	None	View
Cytolytic hepatitis	None	Hepatobiliary disorders	None	View
Hepatic failure	None	Hepatobiliary disorders	None	View
Hepatotoxicity	None	Hepatobiliary disorders	None	View
Hyperbilirubinaemia	None	Hepatobiliary disorders	None	View
Jaundice	None	Hepatobiliary disorders	None	View
Hepatic lesion	None	Hepatobiliary disorders	None	View
Hypersensitivity	None	Immune system disorders	None	View
Anaphylactic shock	None	Immune system disorders	None	View
Sepsis	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Device related infection	None	Infections and infestations	None	View
Gastroenteritis	None	Infections and infestations	None	View
Septic shock	None	Infections and infestations	None	View
Paronychia	None	Infections and infestations	None	View
Abdominal abscess	None	Infections and infestations	None	View
Bacteraemia	None	Infections and infestations	None	View
Bronchopulmonary aspergillosis	None	Infections and infestations	None	View
Candida sepsis	None	Infections and infestations	None	View
Cellulitis	None	Infections and infestations	None	View
Enterocolitis bacterial	None	Infections and infestations	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Herpes zoster	None	Infections and infestations	None	View
Infection	None	Infections and infestations	None	View
Klebsiella sepsis	None	Infections and infestations	None	View
Liver abscess	None	Infections and infestations	None	View
Pneumonia bacterial	None	Infections and infestations	None	View
Respiratory tract infection	None	Infections and infestations	None	View
Skin infection	None	Infections and infestations	None	View
Upper respiratory tract infection	None	Infections and infestations	None	View
Bronchitis	None	Infections and infestations	None	View
Cystitis	None	Infections and infestations	None	View
Gangrene	None	Infections and infestations	None	View
Influenza	None	Infections and infestations	None	View
Oesophageal candidiasis	None	Infections and infestations	None	View
Infusion related reaction	None	Injury, poisoning and procedural complications	None	View
Anastomotic stenosis	None	Injury, poisoning and procedural complications	None	View
Femur fracture	None	Injury, poisoning and procedural complications	None	View
Gastrointestinal stoma complication	None	Injury, poisoning and procedural complications	None	View
Upper limb fracture	None	Injury, poisoning and procedural complications	None	View
Concussion	None	Injury, poisoning and procedural complications	None	View
Fall	None	Injury, poisoning and procedural complications	None	View
Laceration	None	Injury, poisoning and procedural complications	None	View
Overdose	None	Injury, poisoning and procedural complications	None	View
Pneumothorax traumatic	None	Injury, poisoning and procedural complications	None	View
Post procedural discharge	None	Injury, poisoning and procedural complications	None	View
Road traffic accident	None	Injury, poisoning and procedural complications	None	View
Blood bilirubin increased	None	Investigations	None	View
Electrocardiogram QT prolonged	None	Investigations	None	View
Weight decreased	None	Investigations	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Blood creatinine increased	None	Investigations	None	View
Blood urine	None	Investigations	None	View
Electrocardiogram low voltage	None	Investigations	None	View
Glomerular filtration rate decreased	None	Investigations	None	View
International normalised ratio increased	None	Investigations	None	View
Liver function test abnormal	None	Investigations	None	View
Troponin increased	None	Investigations	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Platelet count decreased	None	Investigations	None	View
Prothrombin time prolonged	None	Investigations	None	View
Troponin I increased	None	Investigations	None	View
Decreased appetite	None	Metabolism and nutrition disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hypokalaemia	None	Metabolism and nutrition disorders	None	View
Hypophagia	None	Metabolism and nutrition disorders	None	View
Cachexia	None	Metabolism and nutrition disorders	None	View
Hypocalcaemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	None	Metabolism and nutrition disorders	None	View
Hyponatraemia	None	Metabolism and nutrition disorders	None	View
Diabetes mellitus	None	Metabolism and nutrition disorders	None	View
Electrolyte imbalance	None	Metabolism and nutrition disorders	None	View
Malnutrition	None	Metabolism and nutrition disorders	None	View
Hyperglycaemia	None	Metabolism and nutrition disorders	None	View
Hyperkalaemia	None	Metabolism and nutrition disorders	None	View
Hypoglycaemia	None	Metabolism and nutrition disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Bone pain	None	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal pain	None	Musculoskeletal and connective tissue disorders	None	View
Soft tissue necrosis	None	Musculoskeletal and connective tissue disorders	None	View
Spondylitis	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal chest pain	None	Musculoskeletal and connective tissue disorders	None	View
Tumour haemorrhage	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to ovary	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Neoplasm malignant	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Tumour pain	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Tumour perforation	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Tumour rupture	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to central nervous system	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to meninges	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Tumour associated fever	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Syncope	None	Nervous system disorders	None	View
Cerebral infarction	None	Nervous system disorders	None	View
Ischaemic stroke	None	Nervous system disorders	None	View
Brain stem infarction	None	Nervous system disorders	None	View
Cerebral haemorrhage	None	Nervous system disorders	None	View
Cerebral ischaemia	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Hepatic encephalopathy	None	Nervous system disorders	None	View
Lumbar radiculopathy	None	Nervous system disorders	None	View
Spinal cord compression	None	Nervous system disorders	None	View
Cerebrovascular accident	None	Nervous system disorders	None	View
Convulsion	None	Nervous system disorders	None	View
Depressed level of consciousness	None	Nervous system disorders	None	View
Facial paresis	None	Nervous system disorders	None	View
Hemiparesis	None	Nervous system disorders	None	View
Paraesthesia	None	Nervous system disorders	None	View
Presyncope	None	Nervous system disorders	None	View
Subarachnoid haemorrhage	None	Nervous system disorders	None	View
Delirium	None	Psychiatric disorders	None	View
Depression	None	Psychiatric disorders	None	View
Completed suicide	None	Psychiatric disorders	None	View
Renal failure	None	Renal and urinary disorders	None	View
Renal failure acute	None	Renal and urinary disorders	None	View
Acute prerenal failure	None	Renal and urinary disorders	None	View
Calculus ureteric	None	Renal and urinary disorders	None	View
Haematuria	None	Renal and urinary disorders	None	View
Hydronephrosis	None	Renal and urinary disorders	None	View
Renal colic	None	Renal and urinary disorders	None	View
Renal impairment	None	Renal and urinary disorders	None	View
Ureteric obstruction	None	Renal and urinary disorders	None	View
Urinary retention	None	Renal and urinary disorders	None	View
Oliguria	None	Renal and urinary disorders	None	View
Urinary tract obstruction	None	Renal and urinary disorders	None	View
Benign prostatic hyperplasia	None	Reproductive system and breast disorders	None	View
Pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Bronchospasm	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary artery thrombosis	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary thrombosis	None	Respiratory, thoracic and mediastinal disorders	None	View
Dermatitis	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis acneiform	None	Skin and subcutaneous tissue disorders	None	View
Dry skin	None	Skin and subcutaneous tissue disorders	None	View
Palmar-plantar erythrodysaesthesia syndrome	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Rash generalised	None	Skin and subcutaneous tissue disorders	None	View
Skin disorder	None	Skin and subcutaneous tissue disorders	None	View
Skin exfoliation	None	Skin and subcutaneous tissue disorders	None	View
Skin toxicity	None	Skin and subcutaneous tissue disorders	None	View
Deep vein thrombosis	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Peripheral ischaemia	None	Vascular disorders	None	View
Circulatory collapse	None	Vascular disorders	None	View
Subclavian vein thrombosis	None	Vascular disorders	None	View
Venous thrombosis	None	Vascular disorders	None	View
Venous thrombosis limb	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Hypocalcaemia	None	Metabolism and nutrition disorders	None	View
Hyponatraemia	None	Metabolism and nutrition disorders	None	View
Hypoalbuminaemia	None	Metabolism and nutrition disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hypophosphataemia	None	Metabolism and nutrition disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Peripheral sensory neuropathy	None	Nervous system disorders	None	View
Dysgeusia	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Neuropathy peripheral	None	Nervous system disorders	None	View
Paraesthesia	None	Nervous system disorders	None	View
Insomnia	None	Psychiatric disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Hiccups	None	Respiratory, thoracic and mediastinal disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Neutropenia	None	Blood and lymphatic system disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Leukopenia	None	Blood and lymphatic system disorders	None	View
Palmar-plantar erythrodysaesthesia syndrome	None	Skin and subcutaneous tissue disorders	None	View
Dermatitis acneiform	None	Skin and subcutaneous tissue disorders	None	View
Dry skin	None	Skin and subcutaneous tissue disorders	None	View
Acne	None	Skin and subcutaneous tissue disorders	None	View
Alopecia	None	Skin and subcutaneous tissue disorders	None	View
Skin fissures	None	Skin and subcutaneous tissue disorders	None	View
Skin hyperpigmentation	None	Skin and subcutaneous tissue disorders	None	View
Tinnitus	None	Ear and labyrinth disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Stomatitis	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Abdominal pain upper	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Fatigue	None	General disorders	None	View
Asthenia	None	General disorders	None	View
Mucosal inflammation	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Hyperbilirubinaemia	None	Hepatobiliary disorders	None	View
Paronychia	None	Infections and infestations	None	View
Weight decreased	None	Investigations	None	View
Haemoglobin decreased	None	Investigations	None	View
Glomerular filtration rate decreased	None	Investigations	None	View
Blood creatinine increased	None	Investigations	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Neutrophil count decreased	None	Investigations	None	View
Platelet count decreased	None	Investigations	None	View
Decreased appetite	None	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	None	Metabolism and nutrition disorders	None	View
Hypokalaemia	None	Metabolism and nutrition disorders	None	View