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 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
NCT ID:
NCT01740557
Description:
None
Frequency Threshold:
5
Time Frame:
From Baseline to 1 year follow-up
Study:
NCT01740557
Study Brief:
Genetically Modified Therapeutic Autologous Lymphocytes Followed by Aldesleukin in Treating Patients With Stage III or 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Genetically Modified T-cells, High-dose Aldesleukin | Participants receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and CXCR2-transduced autologous TIL and NGFR-transduced autologous TIL IV over up to 4 hours on day 0. Participants then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses). Aldesleukin: Given IV CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies NGFR-transduced Autologous T Lymphocytes: Given IV Quality-of-Life Assessment: Ancillary studies | 1 | None | 8 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Allergic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE version 4.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Absolute monocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Absolute basophil cound decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Back Pain (right side lower back) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |
| Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Bibasilar | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Diminished lung sounds- right | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Diminished lung sounds- left | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Diminished lung sound bilateral | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Dermititis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Dark discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 4.0 | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| CK increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Decreased protein | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 4.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Edema (face) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Edema (trunk) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| ECG QT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Elevated LDH | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Gastitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Tinea Cruris (fungal goin infection) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Erythematous Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Floaters | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Generalised edema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Generalized erythema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Hypothyrodism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE version 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| INR Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 4.0 | View |
| LDH Increased | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Lymphedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Ionized Calcium | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Ionized Calcium | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE version 4.0 | View |
| Mucosal Infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Alkaline phosphate decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Lung Infection (pneumonia) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Night Sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 4.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Phosphorus increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Protein decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Petechia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Palpations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Paresthesia (left shoulder) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Peripheral sensory neuropathy (bilateral hands/feet) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Rash masculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Seborrheic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Skin Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Sleep Apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Superventricular tachycardis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Sommolence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 4.0 | View |
| Thrush | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Total protein decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| TSH increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Uric acid decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 4.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |
| Lung cracles- right | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 4.0 | View |