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: 2025-12-25 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:30 AM
NCT ID: NCT00154102
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: NCT00154102
Study Brief: Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
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 FOLFIRI Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects. None None 263 600 593 600 View
FOLFIRI Alone Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects None None 204 602 591 602 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIABETES INSIPIDUS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
ABDOMINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal 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
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
PLATELET TOXICITY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ARRHYTHMIA SUPRAVENTRICULAR SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ARTERIOSPASM CORONARY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIAC FAILURE ACUTE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIOGENIC SHOCK SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CARDIOPULMONARY FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
CONDUCTION DISORDER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
MYOCARDIAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
RIGHT VENTRICULAR FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ACUTE ABDOMEN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ANAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASCITES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
COLONIC OBSTRUCTION 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
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ENTEROCOLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ENTEROVESICAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTRO-INTESTINAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTROINTESTINAL HYPOMOTILITY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTROINTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
HAEMATOCHEZIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ILEUS PARALYTIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
INTESTINAL PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
MESENTERIC VEIN THROMBOSIS 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
PERITONEAL EFFUSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
PERITONITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
PROCTALGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
SUBILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
UPPER GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CATHETER RELATED COMPLICATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CATHETER SITE HAEMATOMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CATHETER SITE INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CATHETER SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
EXTRAVASATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFUSION SITE EXTRAVASATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INFUSION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
LOCALISED OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
BILE DUCT STENOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
BILIARY FISTULA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
CHOLANGITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
DILATATION INTRAHEPATIC DUCT ACQUIRED SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.0 View
HEPATIC FAILURE 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
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
ABDOMINAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ABDOMINAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ABSCESS INTESTINAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CATHETER RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CATHETER SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CATHETER SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CELLULITIS 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
ESCHERICHIA BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
LISTERIOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
LUNG ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
NEUTROPENIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
NEUTROPENIC SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
OTITIS MEDIA CHRONIC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PELVIC ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PERIANAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PNEUMONIA KLEBSIELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PNEUMONIA STREPTOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
POSTOPERATIVE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
POSTOPERATIVE WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
PYELONEPHRITIS ACUTE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
RETROPERITONEAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
STAPHYLOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
STREPTOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
VARICELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ALCOHOL POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
ANASTOMOTIC STENOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FEMORAL NECK FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FIBULA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FRACTURED SACRUM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
INTESTINAL STOMA COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
LIMB INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
PATELLA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
POST PROCEDURAL BILE LEAK SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
SPINAL COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
STENT OCCLUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
SUBDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
VASCULAR ACCESS COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
C-REACTIVE PROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
HAEMOGLOBIN DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
LABORATORY TEST ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
URINE ANALYSIS ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
CACHEXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
DIABETIC KETOACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
ELECTROLYTE IMBALANCE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
HYPOGLYCAEMIA 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
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
LACTIC ACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
METABOLIC ACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
ORAL INTAKE REDUCED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
JOINT SWELLING SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
BLADDER NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
CANCER PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
MALIGNANT NEOPLASM PROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
METASTASES TO CENTRAL NERVOUS SYSTEM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
TUMOUR ASSOCIATED FEVER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
TUMOUR HAEMORRHAGE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CEREBRAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
COMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
COORDINATION ABNORMAL SYSTEMATIC_ASSESSMENT Nervous system 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
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SPINAL CORD COMPRESSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
VOCAL CORD PARALYSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
ACUTE CARDIO-VASCULAR INSUFFICIENCY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
ACUTE GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
ACUTE PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CIRCULATORY INSUFFICIENCY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
INFECTION OF OSTEOSYNTHESIS IN RIGHT ANCLE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
THROMBUS//CLOT IN VEIN OF LEFT HAND CAUSING INFECTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
ABNORMAL BEHAVIOUR SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
EUPHORIC MOOD SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
MENTAL STATUS CHANGES SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
CALCULUS URETERIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
CALCULUS URINARY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
HAEMORRHAGE URINARY TRACT SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
HYDRONEPHROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
RENAL COLIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
URETERIC OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
BENIGN PROSTATIC HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
VAGINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PLEURITIC PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
DERMATITIS ACNEIFORM 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
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
CATARACT OPERATION 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
DEEP VEIN THROMBOSIS 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
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
INTERMITTENT CLAUDICATION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
JUGULAR VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
PERIPHERAL OCCLUSIVE DISEASE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
SUBCLAVIAN VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
VENA CAVA THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
VENOUS THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
VENOUS THROMBOSIS LIMB SYSTEMATIC_ASSESSMENT Vascular 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
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
LYMPHOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
PARONYCHIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
NASOPHARYNGITIS 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
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
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DYSGEUSIA 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
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
RASH 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
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
SKIN FISSURES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
NAIL DISORDER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
EXFOLIATIVE RASH 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
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View