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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT00513604
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00513604
Study Brief: Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in 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
Cohort 1 - NMA, TIL, Aldesleukin Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin: Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin. Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days. None None 9 26 24 26 View
Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin: Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin. Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days. None None 8 39 39 39 View
Cohort 3 - NMA, Total Body Irradiation Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI): Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin. Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days. None None 5 24 23 24 View
Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin: Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin. Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days. None None 5 34 34 34 View
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin: Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin. Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days None None 4 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCv3.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Ileal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Leukoencephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Blood and lymphatic system disorders _ Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv3.0 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCv3.0 View
Catheter-related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Electrocardiogram QT corrected interval prolong SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv3.0 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv3.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Blood and lymphatic system disorders _ Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Paroxysmal atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv3.0 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv3.0 View
Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders CTCv3.0 View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCv3.0 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Pyramidal tract syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv3.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv3.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv3.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Palmer-plantar erythrodyesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv3.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv3.0 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv3.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv3.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCv3.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCv3.0 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders CTCv3.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv3.0 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders CTCv3.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv3.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv3.0 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv3.0 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv3.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCv3.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCv3.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv3.0 View