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: 2025-12-24 @ 12:04 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT01595061
Description: None
Frequency Threshold: 0
Time Frame: During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
Study: NCT01595061
Study Brief: Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GEM+CIS+IMRT Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes. 1 None 24 53 53 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vascular Access Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Lymphocyte Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White Blood Cell Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Sudden Death Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Lung Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Platelet Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Muscle Weakness Lower Limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Reproductive System And Breast Disorders - Other NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood And Lymphatic System Disorders - Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Mobitz Type I NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Supraventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Chest Pain - Cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Lower Gastrointestinal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal Disorders - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gingival Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoidal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
General Disorders And Administration Site Conditio NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Localized Edema NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Infections And Infestations - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vulval Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Hepatitis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vaginal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vascular Access Complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Dermatitis Radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Investigations - Other NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight Loss NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood Bilirubin Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White Blood Cell Decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline Phosphatase Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Metabolism And Nutrition Disorders - Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Pain In Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle Weakness Lower Limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized Muscle Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Tumor Pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Cognitive Disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Urine Discoloration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Tract Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Tract Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary Frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Chronic Kidney Disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Bladder Spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Vaginal Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Perineal Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal Discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal Inflammation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Genital Edema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Skin And Subcutaneous Tissue Disorders - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin Ulceration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash Acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Nail Loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Erythroderma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Surgical And Medical Procedures - Other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Thromboembolic Event NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Superficial Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Lymphedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hot Flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Flank Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cystitis Noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pain Of Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash Maculo-Papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Peripheral Sensory Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View