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 @ 9:54 PM
Ignite Modification Date: 2025-12-25 @ 7:32 PM
NCT ID: NCT02511132
Description: None
Frequency Threshold: 3
Time Frame: Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Study: NCT02511132
Study Brief: A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1: Gemicitabine and Docetaxel Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days. Gemcitabine: 675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days Docetaxel: 75 mg/m2 IV administered on Day 8 and every 21 days 8 None 5 8 5 8 View
Part 2: Vigil Plus Temozolomide and Irinotecan (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days. Vigil: Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations. Temozolomide: oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle) Irinotecan: irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously 9 None 5 9 9 9 View
Part 1: Vigil Alone Vigil immunotherapy 1.0 x 107 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days Vigil: Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations. 4 None 2 5 2 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Edema extremities SYSTEMATIC_ASSESSMENT General disorders MedRA View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Brain mass SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Blisters SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Facial swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedRA View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Platelets decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
WBC decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Iron deficiency anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Chronic heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedRA View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Rib pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedRA View
Dry eyes SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Blood in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Reflux esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedRA View
Edema SYSTEMATIC_ASSESSMENT General disorders MedRA View
Edema extremities SYSTEMATIC_ASSESSMENT General disorders MedRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedRA View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedRA View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedRA View
Mucositis SYSTEMATIC_ASSESSMENT General disorders MedRA View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedRA View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Oral thrush SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Herpes dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Platelets decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
WBC decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Breath sounds decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedRA View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Hip discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Jaw pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Swollen ankles SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Foot drop SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Blisters SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Erythroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Facial swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Skin peeling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Diaphoresis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Pale skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
DVT SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View