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 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT00096135
Description: SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Frequency Threshold: 0
Time Frame: None
Study: NCT00096135
Study Brief: Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CNS Patients - Treatment (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT. None None 7 124 119 124 View
Testicular Relapse Patients (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT. None None 1 42 41 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation None Blood and lymphatic system disorders None View
Cardiac disorders - Other None Cardiac disorders None View
Death NOS None General disorders None View
Hepatic failure None Hepatobiliary disorders None View
Blood bilirubin increased None Investigations None View
Fibrinogen decreased None Investigations None View
Platelet count decreased None Investigations None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event None Vascular disorders None View
Aspartate aminotransferase increased None Investigations None View
GGT increased None Investigations None View
INR increased None Investigations None View
White blood cell decreased None Investigations None View
Acidosis None Metabolism and nutrition disorders None View
Infections and infestations - Other None Infections and infestations None View
Lung infection None Infections and infestations None View
Activated partial thromboplastin time prolonged None Investigations None View
Alanine aminotransferase increased None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Blood and lymphatic system disorders - Other None Blood and lymphatic system disorders None View
Disseminated intravascular coagulation None Blood and lymphatic system disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Sinus tachycardia None Cardiac disorders None View
Middle ear inflammation None Ear and labyrinth disorders None View
Extraocular muscle paresis None Eye disorders None View
Eye disorders - Other None Eye disorders None View
Photophobia None Eye disorders None View
Abdominal pain None Gastrointestinal disorders None View
Anal mucositis None Gastrointestinal disorders None View
General disorders and administration site conditions - Other None General disorders None View
Multi-organ failure None General disorders None View
Pain None General disorders None View
Sudden death NOS None General disorders None View
Hepatic failure None Hepatobiliary disorders None View
Allergic reaction None Immune system disorders None View
Anaphylaxis None Immune system disorders None View
Cytokine release syndrome None Immune system disorders None View
Immune system disorders - Other None Immune system disorders None View
Serum sickness None Immune system disorders None View
Abdominal infection None Infections and infestations None View
Anorectal infection None Infections and infestations None View
Arteritis infective None Infections and infestations None View
Bladder infection None Infections and infestations None View
Bronchial infection None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Enterocolitis infectious None Infections and infestations None View
Eye infection None Infections and infestations None View
Gum infection None Infections and infestations None View
Infections and infestations - Other None Infections and infestations None View
Sinusitis None Infections and infestations None View
Skin infection None Infections and infestations None View
Cholesterol high None Investigations None View
Creatinine increased None Investigations None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Fibrinogen decreased None Investigations None View
GGT increased None Investigations None View
Investigations - Other None Investigations None View
Lipase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
Serum amylase increased None Investigations None View
Weight gain None Investigations None View
White blood cell decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Renal calculi None Renal and urinary disorders None View
Urinary tract obstruction None Renal and urinary disorders None View
Urinary tract pain None Renal and urinary disorders None View
Penile pain None Reproductive system and breast disorders None View
Perineal pain None Reproductive system and breast disorders None View
Vaginal inflammation None Reproductive system and breast disorders None View
Apnea None Respiratory, thoracic and mediastinal disorders None View
Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Hiccups None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders None View
Pain of skin None Skin and subcutaneous tissue disorders None View
Purpura None Skin and subcutaneous tissue disorders None View
Rash acneiform None Skin and subcutaneous tissue disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other None Skin and subcutaneous tissue disorders None View
Capillary leak syndrome None Vascular disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Thromboembolic event None Vascular disorders None View
Vascular disorders - Other None Vascular disorders None View
Anal pain None Gastrointestinal disorders None View
Colitis None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Esophagitis None Gastrointestinal disorders None View
Gastrointestinal disorders - Other None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Mucositis oral None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Oral pain None Gastrointestinal disorders None View
Pancreatitis None Gastrointestinal disorders None View
Rectal mucositis None Gastrointestinal disorders None View
Rectal pain None Gastrointestinal disorders None View
Stomach pain None Gastrointestinal disorders None View
Typhlitis None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Death NOS None General disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Flu like symptoms None General disorders None View
Joint infection None Infections and infestations None View
Lung infection None Infections and infestations None View
Meningitis None Infections and infestations None View
Mucosal infection None Infections and infestations None View
Otitis externa None Infections and infestations None View
Otitis media None Infections and infestations None View
Penile infection None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Salivary gland infection None Infections and infestations None View
Sepsis None Infections and infestations None View
Small intestine infection None Infections and infestations None View
Upper respiratory infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Wound infection None Infections and infestations None View
Dermatitis radiation None Injury, poisoning and procedural complications None View
Fracture None Injury, poisoning and procedural complications None View
Intraoperative venous injury None Injury, poisoning and procedural complications None View
Activated partial thromboplastin time prolonged None Investigations None View
Alanine aminotransferase increased None Investigations None View
Alkaline phosphatase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Blood bilirubin increased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Glucose intolerance None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypertriglyceridemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Avascular necrosis None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb None Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Myositis None Musculoskeletal and connective tissue disorders None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Ataxia None Nervous system disorders None View
Cognitive disturbance None Nervous system disorders None View
Depressed level of consciousness None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Dysphasia None Nervous system disorders None View
Headache None Nervous system disorders None View
Memory impairment None Nervous system disorders None View
Neuralgia None Nervous system disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Seizure None Nervous system disorders None View
Sinus pain None Nervous system disorders None View
Syncope None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Confusion None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Personality change None Psychiatric disorders None View
Psychosis None Psychiatric disorders None View
Acute kidney injury None Renal and urinary disorders None View
Proteinuria None Renal and urinary disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other None Respiratory, thoracic and mediastinal disorders None View