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 @ 12:28 AM
Ignite Modification Date: 2025-12-25 @ 10:35 PM
NCT ID: NCT00805467
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00805467
Study Brief: Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
100 MG BID None None None 77 381 306 381 View
100 MG QD None None None 2 59 49 59 View
150 MG QD None None None 34 183 141 183 View
50 MG BID None None None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
THROMBOTIC THROMBOCYTOPENIC PURPURA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
ARTERIOSPASM CORONARY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIOPULMONARY FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
INTRACARDIAC THROMBUS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
VENTRICULAR DYSFUNCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
GOITRE SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.1 View
PANOPHTHALMITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
COLITIS MICROSCOPIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
PANCREATITIS HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
RECTAL PROLAPSE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
DEVICE DISLOCATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
HEPATIC CIRRHOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
HEPATIC STEATOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
ABSCESS SOFT TISSUE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
BURSITIS INFECTIVE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
GIARDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
INFECTED BITES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
LOBAR PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
MENINGITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
NECROTISING FASCIITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PERITONITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PNEUMONIA STAPHYLOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
UROSEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
VARICELLA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
WOUND INFECTION STAPHYLOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
BRAIN NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
ACUTE POLYNEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
LUMBAR RADICULOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
RADICULOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
ABORTION SPONTANEOUS SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.1 View
ABORTION SPONTANEOUS INCOMPLETE SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
RENAL FAILURE ACUTE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
ENDOMETRIAL HYPERTROPHY SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
POSTMENOPAUSAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
VAGINAL PROLAPSE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
LUNG INFILTRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PULMONARY FIBROSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
HIP ARTHROPLASTY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
IMPLANTABLE DEFIBRILLATOR INSERTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
KNEE ARTHROPLASTY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
AORTIC ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
ARTERIOSCLEROSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
SPINAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
DIVERTICULUM SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
FAECALOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRIC PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTROINTESTINAL PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
CYTOMEGALOVIRUS HEPATITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
CYTOMEGALOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
DYSENTERY SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
EPIGLOTTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ERYTHEMA MIGRANS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
DISLOCATION OF VERTEBRA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
JOINT DISLOCATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
MUSCLE RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
PUBIS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
SUBDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
CERVICAL SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
LUMBAR SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MYOSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
RHEUMATOID ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
SPINAL OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
ANAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
BASOSQUAMOUS CARCINOMA OF SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
CERVIX CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
COLON CANCER STAGE IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
DIFFUSE LARGE B-CELL LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
LARGE INTESTINE CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
PARATHYROID TUMOUR BENIGN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
THYROID CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
COLONIC POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
UTERINE LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
BURSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
RHEUMATOID ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
TENDONITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HYPERTONIC BLADDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
SKIN LESION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
TRANSAMINASES INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
HYPERLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View