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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT00866918
Description: Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
Frequency Threshold: 0
Time Frame: None
Study: NCT00866918
Study Brief: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Risk WBC\<10,000/MicroLiter None None 17 66 61 66 View
High Risk WBC\>=10,000/MicroLiter None None 14 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Acidosis None Metabolism and nutrition disorders None View
Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders None View
Alanine aminotransferase increased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Aspartate aminotransferase increased None Investigations None View
Asystole None Cardiac disorders None View
Blood bilirubin increased None Investigations None View
Bronchial infection None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Dehydration None Metabolism and nutrition disorders None View
Depression None Psychiatric disorders None View
Disseminated intravascular coagulation None Blood and lymphatic system disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Endocarditis infective None Infections and infestations None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Fever None General disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
INR increased None Investigations None View
Multi-organ failure None General disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Pain None General disorders None View
Platelet count decreased None Investigations None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Sepsis None Infections and infestations None View
Sinus tachycardia None Cardiac disorders None View
Skin infection None Infections and infestations None View
Syncope None Nervous system disorders None View
Treatment related secondary malignancy None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Urinary tract infection None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
White blood cell decreased None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Alanine aminotransferase increased None Investigations None View
Alkaline phosphatase increased None Investigations None View
Allergic reaction None Immune system disorders None View
Anal pain None Gastrointestinal disorders None View
Anemia None Blood and lymphatic system disorders None View
Bone infection None Infections and infestations None View
Bronchial infection None Infections and infestations None View
Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Ear pain None Ear and labyrinth disorders None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Hematoma None Vascular disorders None View
Hematuria None Renal and urinary disorders None View
Hepatic infection None Infections and infestations None View
Hypercalcemia None Metabolism and nutrition disorders None View
Insomnia None Psychiatric disorders None View
Intracranial hemorrhage None Nervous system disorders None View
Investigations - Other, specify None Investigations None View
Laryngeal mucositis None Respiratory, thoracic and mediastinal disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nervous system disorders - Other, specify None Nervous system disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Rectal fistula None Gastrointestinal disorders None View
Skin ulceration None Skin and subcutaneous tissue disorders None View
Small intestine infection None Infections and infestations None View
Soft tissue infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Vaginal infection None Infections and infestations None View
Vascular access complication None Injury, poisoning and procedural complications None View
Catheter related infection None Infections and infestations None View
Cholecystitis None Hepatobiliary disorders None View
Colitis None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Creatinine increased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Depression None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Disseminated intravascular coagulation None Blood and lymphatic system disorders None View
Dysarthria None Nervous system disorders None View
Dysphagia None Gastrointestinal disorders None View
Enterocolitis None Gastrointestinal disorders None View
Enterocolitis infectious None Infections and infestations None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Esophageal infection None Infections and infestations None View
Esophageal pain None Gastrointestinal disorders None View
Esophageal ulcer None Gastrointestinal disorders None View
Esophagitis None Gastrointestinal disorders None View
Eye disorders - Other, specify None Eye disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Fever None General disorders None View
Fibrinogen decreased None Investigations None View
Gastritis None Gastrointestinal disorders None View
GGT increased None Investigations None View
Headache None Nervous system disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypertriglyceridemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Laryngeal obstruction None Respiratory, thoracic and mediastinal disorders None View
Lip infection None Infections and infestations None View
Lipase increased None Investigations None View
Lung infection None Infections and infestations None View
Lymph gland infection None Infections and infestations None View
Lymphocyte count decreased None Investigations None View
Metabolism and nutrition disorders - Other, specify None Metabolism and nutrition disorders None View
Mucosal infection None Infections and infestations None View
Mucositis oral None Gastrointestinal disorders None View
Muscle weakness right-sided None Musculoskeletal and connective tissue disorders None View
Nail infection None Infections and infestations None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Oral hemorrhage None Gastrointestinal disorders None View
Oral pain None Gastrointestinal disorders None View
Otitis externa None Infections and infestations None View
Otitis media None Infections and infestations None View
Pain None General disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Pain of skin None Skin and subcutaneous tissue disorders None View
Pancreatitis None Gastrointestinal disorders None View
Papilledema None Eye disorders None View
Papulopustular rash None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Platelet count decreased None Investigations None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pleural hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Rectal hemorrhage None Gastrointestinal disorders None View
Rectal pain None Gastrointestinal disorders None View
Renal and urinary disorders - Other, specify None Renal and urinary disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders None View
Retinoic acid syndrome None Respiratory, thoracic and mediastinal disorders None View
Retinopathy None Eye disorders None View
Sepsis None Infections and infestations None View
Sinusitis None Infections and infestations None View
Skin and subcutaneous tissue disorders - Other, specify None Skin and subcutaneous tissue disorders None View
Skin infection None Infections and infestations None View
Sore throat None Respiratory, thoracic and mediastinal disorders None View
Splenic infection None Infections and infestations None View
Stoma site infection None Infections and infestations None View
Stridor None Respiratory, thoracic and mediastinal disorders None View
Suicide attempt None Psychiatric disorders None View
Surgical and medical procedures - Other, specify None Surgical and medical procedures None View
Thromboembolic event None Vascular disorders None View
Tooth infection None Infections and infestations None View
Toothache None Gastrointestinal disorders None View
Tracheal stenosis None Respiratory, thoracic and mediastinal disorders None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View
Typhlitis None Gastrointestinal disorders None View
Upper respiratory infection None Infections and infestations None View
Ventricular arrhythmia None Cardiac disorders None View
Ventricular tachycardia None Cardiac disorders None View
Vitreous hemorrhage None Eye disorders None View
Vomiting None Gastrointestinal disorders None View
Vulval infection None Infections and infestations None View
Weight gain None Investigations None View
Weight loss None Investigations None View
White blood cell decreased None Investigations None View
Wound infection None Infections and infestations None View
Acidosis None Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged None Investigations None View
Acute kidney injury None Renal and urinary disorders None View
Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders None View
Agitation None Psychiatric disorders None View
Anorectal infection None Infections and infestations None View
Anorexia None Metabolism and nutrition disorders None View
Appendicitis None Infections and infestations None View
Appendicitis perforated None Infections and infestations None View
Arachnoiditis None Nervous system disorders None View
Ascites None Gastrointestinal disorders None View
Aspartate aminotransferase increased None Investigations None View
Atelectasis None Respiratory, thoracic and mediastinal disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Blood and lymphatic system disorders - Other, specify None Blood and lymphatic system disorders None View
Blood bilirubin increased None Investigations None View
Bronchospasm None Respiratory, thoracic and mediastinal disorders None View
Cardiac disorders - Other, specify None Cardiac disorders None View