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 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
NCT ID:
NCT01228734
Description:
Modified safety population included all subjects with RAS wild type tumor status who received any study treatment (cetuximab, oxaliplatin or 5-FU/FA). Subjects were analyzed as treated.
Frequency Threshold:
5
Time Frame:
Baseline up to Safety Follow up (assessed up to 333 weeks)
Study:
NCT01228734
Study Brief:
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
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 + FOLFOX-4 | Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\^2 at 5 mg/min and 250 mg/m\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\^2/day intravenously over 2-4 minutes followed by 600 mg/m\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. | 157 | None | 42 | 194 | 194 | 194 | View |
| FOLFOX-4 | Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\^2/day intravenously over 2-4 minutes followed by 600 mg/m\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. | 173 | None | 27 | 199 | 194 | 199 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SUDDEN DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| BONE MARROW FAILURE | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| FEBRILE NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| THROMBOCYTOPENIC PURPURA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| ATRIAL FLUTTER | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| VENTRICULAR TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| RETINAL DETACHMENT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| ANAL FISTULA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| ENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| INCARCERATED INGUINAL HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| INTESTINAL PERFORATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| LARGE INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| MULTI-ORGAN FAILURE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| CHOLECYSTITIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| HEPATIC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| HYPERBILIRUBINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| JAUNDICE CHOLESTATIC | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| DRUG HYPERSENSITIVITY | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.1 | View |
| ANAL ABSCESS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| EPIDIDYMITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| SEPTIC SHOCK | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| STAPHYLOCOCCAL BACTERAEMIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| STAPHYLOCOCCAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| TYPE 2 DIABETES MELLITUS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| CEREBRAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| HEPATIC ENCEPHALOPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| SUICIDE ATTEMPT | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| RENAL FAILURE | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| URETERIC OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| DYSPNOEA AT REST | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| AXILLARY VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| JUGULAR VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| PHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| SUBCLAVIAN VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| VENOUS THROMBOSIS LIMB | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| THROMBOCYTOPENIC PURPURA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| LARGE INTESTINE POLYP | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| INFUSION SITE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| COLON CANCER METASTATIC | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| BONE MARROW FAILURE | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| ABDOMINAL DISTENSION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| HAEMATOCHEZIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| MOUTH ULCERATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| HYPERBILIRUBINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| LIVER INJURY | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| DRUG HYPERSENSITIVITY | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.1 | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| PARONYCHIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| INFUSION RELATED REACTION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| BLOOD ALBUMIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| BLOOD BILIRUBIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| NEUTROPHIL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPERGLYCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPOALBUMINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPOCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPOPHOSPHATAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| HYPOAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| NEUROTOXICITY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| SKIN FISSURES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| HYPOMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| HYPOPROTEINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |