Adverse Events Module

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 @ 1:04 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT00423293
Description: Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Frequency Threshold: 0
Time Frame: None
Study: NCT00423293
Study Brief: Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5-FU + Mitomycin + IMRT 5-FU + Mitomycin + IMRT None None 6 52 52 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Vascular access complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary tract obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Perineal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nervous system disorders - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urine discoloration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Irregular menstruation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Blood and lymphatic system disorders - Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cardiac disorders - Other NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Paroxysmal atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colonic hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Duodenal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Esophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrointestinal disorders - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Lower gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rectal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rectal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death NOS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Edema trunk NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
General disorders and administration site conditions - Other NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hepatobiliary disorders - Other NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infections and infestations - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Radiation recall reaction (dermatologic) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Vascular access complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
CD4 lymphocytes decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
CPK increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Investigations - Other NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Buttock pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle weakness right-sided NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Musculoskeletal and connective tissue disorder - Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pelvic soft tissue necrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Libido decreased NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Renal and urinary disorders - Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Penile pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Perineal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Reproductive system and breast disorders - Other NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Scrotal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal dryness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal inflammation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal obstruction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Vaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Respiratory, thoracic and mediastinal disorders - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin and subcutaneous tissue disorders - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin atrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin hypopigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin induration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin ulceration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Telangiectasia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Vascular disorders - Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View