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: 2025-12-24 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT00354835
Description: All eligible patients were considered in the evaluation of adverse events.
Frequency Threshold: 0
Time Frame: None
Study: NCT00354835
Study Brief: Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vincristine, Dactinomycin, Cyclophosphamide (VAC) Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies None None 4 222 209 222 View
VAC Alternating With VI Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Irinotecan Hydrochloride: Given IV Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies None None 11 226 213 226 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased None Investigations CTCv4 View
Anemia None Blood and lymphatic system disorders CTCv4 View
Ascites None Gastrointestinal disorders CTCv4 View
Aspartate aminotransferase increased None Investigations CTCv4 View
Blood bilirubin increased None Investigations CTCv4 View
Death NOS None General disorders CTCv4 View
Encephalopathy None Nervous system disorders CTCv4 View
Esophagitis None Gastrointestinal disorders CTCv4 View
Gastritis None Gastrointestinal disorders CTCv4 View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders CTCv4 View
Hepatic pain None Hepatobiliary disorders CTCv4 View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders CTCv4 View
Hypokalemia None Metabolism and nutrition disorders CTCv4 View
Hyponatremia None Metabolism and nutrition disorders CTCv4 View
Intracranial hemorrhage None Nervous system disorders CTCv4 View
Lymphocyte count decreased None Investigations CTCv4 View
Mucositis oral None Gastrointestinal disorders CTCv4 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
Nervous system disorders - Other, specify None Nervous system disorders CTCv4 View
Oral pain None Gastrointestinal disorders CTCv4 View
Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders CTCv4 View
Platelet count decreased None Investigations CTCv4 View
Pneumothorax None Respiratory, thoracic and mediastinal disorders CTCv4 View
Radiation recall reaction (dermatologic) None Injury, poisoning and procedural complications CTCv4 View
Sepsis None Infections and infestations CTCv4 View
Tracheal obstruction None Injury, poisoning and procedural complications CTCv4 View
Treatment related secondary malignancy None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash maculo-papular None Skin and subcutaneous tissue disorders CTCv4 View
Rectal pain None Gastrointestinal disorders CTCv4 View
Recurrent laryngeal nerve palsy None Nervous system disorders CTCv4 View
Typhlitis None Gastrointestinal disorders CTCv4 View
Upper respiratory infection None Infections and infestations CTCv4 View
Urethral infection None Infections and infestations CTCv4 View
Urinary retention None Renal and urinary disorders CTCv4 View
Urinary tract infection None Infections and infestations CTCv4 View
Urinary tract obstruction None Renal and urinary disorders CTCv4 View
Urticaria None Skin and subcutaneous tissue disorders CTCv4 View
Vaginal infection None Infections and infestations CTCv4 View
Vaginal pain None Reproductive system and breast disorders CTCv4 View
Vagus nerve disorder None Nervous system disorders CTCv4 View
Abdominal distension None Gastrointestinal disorders CTCv4 View
Abdominal infection None Infections and infestations CTCv4 View
Abdominal pain None Gastrointestinal disorders CTCv4 View
Abducens nerve disorder None Nervous system disorders CTCv4 View
Activated partial thromboplastin time prolonged None Investigations CTCv4 View
Alanine aminotransferase increased None Investigations CTCv4 View
Alkaline phosphatase increased None Investigations CTCv4 View
Anal mucositis None Gastrointestinal disorders CTCv4 View
Dermatitis radiation None Injury, poisoning and procedural complications CTCv4 View
Device related infection None Infections and infestations CTCv4 View
Diarrhea None Gastrointestinal disorders CTCv4 View
Dizziness None Nervous system disorders CTCv4 View
Dry mouth None Gastrointestinal disorders CTCv4 View
Dysesthesia None Nervous system disorders CTCv4 View
Dysphagia None Gastrointestinal disorders CTCv4 View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCv4 View
Edema trunk None General disorders CTCv4 View
Encephalopathy None Nervous system disorders CTCv4 View
Enterocolitis None Gastrointestinal disorders CTCv4 View
Enterocolitis infectious None Infections and infestations CTCv4 View
Epistaxis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Esophageal infection None Infections and infestations CTCv4 View
Esophagitis None Gastrointestinal disorders CTCv4 View
External ear inflammation None Ear and labyrinth disorders CTCv4 View
Extraocular muscle paresis None Eye disorders CTCv4 View
Eye disorders - Other, specify None Eye disorders CTCv4 View
Eye infection None Infections and infestations CTCv4 View
Eyelid function disorder None Eye disorders CTCv4 View
General disorders and administration site conditions - Other, specify None General disorders CTCv4 View
GGT increased None Investigations CTCv4 View
Gum infection None Infections and infestations CTCv4 View
Headache None Nervous system disorders CTCv4 View
Hearing impaired None Ear and labyrinth disorders CTCv4 View
Hematuria None Renal and urinary disorders CTCv4 View
Hemoglobin increased None Investigations CTCv4 View
Hepatic pain None Hepatobiliary disorders CTCv4 View
Hyperglycemia None Metabolism and nutrition disorders CTCv4 View
Hyperkalemia None Metabolism and nutrition disorders CTCv4 View
Hypermagnesemia None Metabolism and nutrition disorders CTCv4 View
Hypernatremia None Metabolism and nutrition disorders CTCv4 View
Hypertension None Vascular disorders CTCv4 View
Hypoalbuminemia None Metabolism and nutrition disorders CTCv4 View
Hypocalcemia None Metabolism and nutrition disorders CTCv4 View
Hypoglossal nerve disorder None Nervous system disorders CTCv4 View
Hypoglycemia None Metabolism and nutrition disorders CTCv4 View
Hypokalemia None Metabolism and nutrition disorders CTCv4 View
Hyponatremia None Metabolism and nutrition disorders CTCv4 View
Hypophosphatemia None Metabolism and nutrition disorders CTCv4 View
Lymphocyte count decreased None Investigations CTCv4 View
Neuralgia None Nervous system disorders CTCv4 View
Neutrophil count decreased None Investigations CTCv4 View
Nystagmus None Nervous system disorders CTCv4 View
Renal and urinary disorders - Other, specify None Renal and urinary disorders CTCv4 View
Respiratory failure None Respiratory, thoracic and mediastinal disorders CTCv4 View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders CTCv4 View
Sepsis None Infections and infestations CTCv4 View
Seroma None Injury, poisoning and procedural complications CTCv4 View
Serum amylase increased None Investigations CTCv4 View
Sinus pain None Nervous system disorders CTCv4 View
Sinusitis None Infections and infestations CTCv4 View
Skin and subcutaneous tissue disorders - Other, specify None Skin and subcutaneous tissue disorders CTCv4 View
Skin infection None Infections and infestations CTCv4 View
Small intestine infection None Infections and infestations CTCv4 View
Soft tissue infection None Infections and infestations CTCv4 View
Stomach pain None Gastrointestinal disorders CTCv4 View
Stridor None Respiratory, thoracic and mediastinal disorders CTCv4 View
Syncope None Nervous system disorders CTCv4 View
Thromboembolic event None Vascular disorders CTCv4 View
Tracheal mucositis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Trismus None Musculoskeletal and connective tissue disorders CTCv4 View
Tumor pain None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
Vascular access complication None Injury, poisoning and procedural complications CTCv4 View
Vascular disorders - Other, specify None Vascular disorders CTCv4 View
Vasovagal reaction None Nervous system disorders CTCv4 View
Ventricular fibrillation None Cardiac disorders CTCv4 View
Voice alteration None Respiratory, thoracic and mediastinal disorders CTCv4 View
Vomiting None Gastrointestinal disorders CTCv4 View
Vulval infection None Infections and infestations CTCv4 View
Watering eyes None Eye disorders CTCv4 View
Weight gain None Investigations CTCv4 View
Weight loss None Investigations CTCv4 View
Wheezing None Respiratory, thoracic and mediastinal disorders CTCv4 View
White blood cell decreased None Investigations CTCv4 View
Wound complication None Injury, poisoning and procedural complications CTCv4 View
Wound dehiscence None Injury, poisoning and procedural complications CTCv4 View
Wound infection None Infections and infestations CTCv4 View
Oculomotor nerve disorder None Nervous system disorders CTCv4 View
Optic nerve disorder None Eye disorders CTCv4 View
Oral pain None Gastrointestinal disorders CTCv4 View
Otitis media None Infections and infestations CTCv4 View
Pain None General disorders CTCv4 View
Pain in extremity None Musculoskeletal and connective tissue disorders CTCv4 View
Paronychia None Infections and infestations CTCv4 View
Penile pain None Reproductive system and breast disorders CTCv4 View
Peripheral motor neuropathy None Nervous system disorders CTCv4 View
Peripheral sensory neuropathy None Nervous system disorders CTCv4 View
Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders CTCv4 View
Platelet count decreased None Investigations CTCv4 View
Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pleural infection None Infections and infestations CTCv4 View
Portal hypertension None Hepatobiliary disorders CTCv4 View
Psychiatric disorders - Other, specify None Psychiatric disorders CTCv4 View
Radiation recall reaction (dermatologic) None Injury, poisoning and procedural complications CTCv4 View
Anal pain None Gastrointestinal disorders CTCv4 View
Anaphylaxis None Immune system disorders CTCv4 View
Anemia None Blood and lymphatic system disorders CTCv4 View
Anorectal infection None Infections and infestations CTCv4 View
Anorexia None Metabolism and nutrition disorders CTCv4 View
Aphonia None Nervous system disorders CTCv4 View
Appendicitis None Infections and infestations CTCv4 View
Arthralgia None Musculoskeletal and connective tissue disorders CTCv4 View
Aspartate aminotransferase increased None Investigations CTCv4 View
Ataxia None Nervous system disorders CTCv4 View
Atelectasis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Back pain None Musculoskeletal and connective tissue disorders CTCv4 View
Bladder infection None Infections and infestations CTCv4 View
Bladder spasm None Renal and urinary disorders CTCv4 View
Blood bilirubin increased None Investigations CTCv4 View
Bone pain None Musculoskeletal and connective tissue disorders CTCv4 View
Bronchial infection None Infections and infestations CTCv4 View
Cardiac arrest None Cardiac disorders CTCv4 View
Catheter related infection None Infections and infestations CTCv4 View
Cholecystitis None Hepatobiliary disorders CTCv4 View
Cognitive disturbance None Nervous system disorders CTCv4 View
Colitis None Gastrointestinal disorders CTCv4 View
Confusion None Psychiatric disorders CTCv4 View
Conjunctivitis infective None Infections and infestations CTCv4 View
Constipation None Gastrointestinal disorders CTCv4 View
Cough None Respiratory, thoracic and mediastinal disorders CTCv4 View
Cystitis noninfective None Renal and urinary disorders CTCv4 View
Dehydration None Metabolism and nutrition disorders CTCv4 View
Depressed level of consciousness None Nervous system disorders CTCv4 View
Depression None Psychiatric disorders CTCv4 View
Facial nerve disorder None Nervous system disorders CTCv4 View
Facial pain None General disorders CTCv4 View
Fatigue None General disorders CTCv4 View
Febrile neutropenia None Blood and lymphatic system disorders CTCv4 View
Fever None General disorders CTCv4 View
Fracture None Injury, poisoning and procedural complications CTCv4 View
Gastritis None Gastrointestinal disorders CTCv4 View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders CTCv4 View
Hypotension None Vascular disorders CTCv4 View
Hypoxia None Respiratory, thoracic and mediastinal disorders CTCv4 View
Ileus None Gastrointestinal disorders CTCv4 View
Infections and infestations - Other, specify None Infections and infestations CTCv4 View
Insomnia None Psychiatric disorders CTCv4 View
Investigations - Other, specify None Investigations CTCv4 View
Laryngeal edema None Respiratory, thoracic and mediastinal disorders CTCv4 View
Laryngeal mucositis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Lipase increased None Investigations CTCv4 View
Lung infection None Infections and infestations CTCv4 View
Metabolism and nutrition disorders - Other, specify None Metabolism and nutrition disorders CTCv4 View
Mucositis oral None Gastrointestinal disorders CTCv4 View
Muscle weakness lower limb None Musculoskeletal and connective tissue disorders CTCv4 View
Muscle weakness upper limb None Musculoskeletal and connective tissue disorders CTCv4 View
Musculoskeletal and connective tissue disorder - Other, specify None Musculoskeletal and connective tissue disorders CTCv4 View
Nausea None Gastrointestinal disorders CTCv4 View
Neck pain None Musculoskeletal and connective tissue disorders CTCv4 View
Nervous system disorders - Other, specify None Nervous system disorders CTCv4 View