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 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
NCT ID:
NCT00125034
Description:
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
Frequency Threshold:
5
Time Frame:
Time from first dose up to 30 days after the last dose of study treatment.
Study:
NCT00125034
Study Brief:
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
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 FOLFOX-4 | Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects. | None | None | 61 | 170 | 170 | 170 | View |
| FOLFOX-4 Alone | 5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects. | None | None | 43 | 168 | 165 | 168 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| FEBRILE BONE MARROW APLASIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| ARRHYTHMIA SUPRAVENTRICULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| GASTROINTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| HAEMATEMESIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| LARGE INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| PERITONITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| RECTAL STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| INJECTION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| MASS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| OBSTRUCTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| BILE DUCT STONE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| CHOLANGITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| HEPATORENAL SYNDROME | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| JAUNDICE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| ABSCESS NECK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| CATHETER RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| CENTRAL LINE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| FEBRILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| KIDNEY INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| LUNG ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| PERITONITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| PULMONARY TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| INCISIONAL HERNIA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| WOUND DEHISCENCE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| DIABETES MELLITUS INADEQUATE CONTROL | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| ALCOHOLIC PSYCHOSIS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| MEDIASTINAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| TACHYPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| ILEOCOLOSTOMY | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.0) | View |
| AXILLARY VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| CIRCULATORY COLLAPSE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| INTERMITTENT CLAUDICATION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| SUBILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (10.0) | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| NEUROTOXICITY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| DERMATITIS ACNEIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| EXFOLIATIVE RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| NAIL DISORDER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| SKIN FISSURES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| SKIN TOXICITY | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |