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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT01659151
Description: None
Frequency Threshold: 0
Time Frame: 6 months after end of last treatment, an average of 17 months
Study: NCT01659151
Study Brief: Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Combination Therapy Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2). High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells. ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL). Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years. Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion. 4 None 13 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracranial Hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Treatment related secondary malignancy NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Death - NOS NON_SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other, specify - anasarca NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tumor pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Immune system disorders - Other, specify - guillian barre syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral dysesthesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT corrected interval prolonged NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac troponin T increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cholesterol high NON_SYSTEMATIC_ASSESSMENT Investigations None View
CPK increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Urine output decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism and nutrition disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Photosensitivity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bullous dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood and lymphatic system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vasovagal reaction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Papulopustular rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Salivary gland infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Uveitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Flashing lights NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Capillary leak syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vascular access complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury, poisoning and procedural complications - Other, specify NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arterial injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Treatment related secondary malignancy NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Tumor pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hearing impaired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear and labyrinth disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal and urinary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal calculi NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Immune system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Irregular menstruation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Reproductive system and breast disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal dryness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoidal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Endocrine disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Menopause NON_SYSTEMATIC_ASSESSMENT Social circumstances None View