Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT00508404
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 6.6 months.
Study: NCT00508404
Study Brief: Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal 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
Panitumumab Plus FOLFIRI Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression. None None 84 154 154 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
MYOPERICARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
OCULAR TOXICITY SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ANAL FISSURE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DIARRHOEA HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
FAECALOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
GASTROINTESTINAL INFLAMMATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ILEUS PARALYTIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
INTESTINAL PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
LARGE INTESTINE PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
MELAENA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
SUBILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CATHETER RELATED COMPLICATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
BILIARY DILATATION SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
CHOLESTASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
HEPATIC LESION SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
CATHETER RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
ERYSIPELAS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
HERPES SIMPLEX SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
INTERVERTEBRAL DISCITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PARONYCHIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PERITONEAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
SUBCUTANEOUS ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
GASTROINTESTINAL STOMA COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
HUMERUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
IATROGENIC INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
SPINAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
ELECTROLYTE IMBALANCE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
METABOLIC DISORDER SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
PODAGRA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
BURSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
OSTEOPOROTIC FRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
COLORECTAL CANCER METASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
INTRACRANIAL VENOUS SINUS THROMBOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
VASCULITIS CEREBRAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
HYDRONEPHROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
PYELOCALIECTASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
RENAL COLIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
BENIGN PROSTATIC HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
PROSTATITIS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
LARYNGOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
PULMONARY THROMBOSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
SKIN FISSURES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
VENA CAVA THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
APHTHOUS STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PARONYCHIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
POLYNEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
ACNE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
NAIL TOXICITY SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
SKIN FISSURES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
SKIN TOXICITY SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View