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: 2025-12-25 @ 5:07 AM
Ignite Modification Date: 2025-12-26 @ 4:11 AM
NCT ID: NCT00049127
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00049127
Study Brief: Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study 2 Arm A Phase II patients on EIACs and \<=2 prior regimens None None 0 0 0 0 View
Study 2 Arm B Phase II patients not on EIACs and \<=2 prior regimens None None 12 39 37 39 View
Study 1 Arm C Phase I patients on EIACs and \<=2 prior regimens None None 2 12 12 12 View
Study 3 Arm D Phase II patients on EIACs and \>2 prior regimens None None 0 0 0 0 View
Study 3 Arm E Phase II patients not on EIACs and \>2 prior regimens None None 3 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Hemoglobin for leukemia studies SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea patients with a colostomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Wound-infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Leukocytes for pediatric BMT studies SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Cognitive disturbance/learning problems (for pediatrics) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Neuropathy - cranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View