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 @ 4:25 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT00001566
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00001566
Study Brief: A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes. None None 15 42 27 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain or cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CPK (Creatine phosphokinase) SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DVT (deep vein thrombosis) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elevated total bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Investigations None View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophils SYSTEMATIC_ASSESSMENT Investigations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash with macules/papules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bilateral flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bitter taste in mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bruise SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chelitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cold SYSTEMATIC_ASSESSMENT General disorders None View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough (dry) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough (mild, intermittent) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough nonproductive SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cranky SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased flexibility swelling left leg SYSTEMATIC_ASSESSMENT General disorders None View
Decreased uric acid SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased urine output (o/p) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Discoloration skin (L) hand SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizzy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Double vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Drainage on foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry heaves SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry lips SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry scaly peeling skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry scaly skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear pain/infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ears ringing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ears ringing and clogged SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Edema media R mid-thigh SYSTEMATIC_ASSESSMENT General disorders None View
Edema on foot SYSTEMATIC_ASSESSMENT General disorders None View
Edema, facial SYSTEMATIC_ASSESSMENT General disorders None View
Elevated creat SYSTEMATIC_ASSESSMENT Investigations None View
Elevated creatin SYSTEMATIC_ASSESSMENT Investigations None View
Elevated D bili SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated LFT's (liver function tests) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated magnesium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated SGOT(serum glutamic oxaloacetic transaminase) SYSTEMATIC_ASSESSMENT Investigations None View
Elevated SGPT (serum glutamic pyruvic transaminase) SYSTEMATIC_ASSESSMENT Investigations None View
Elevated BUN SYSTEMATIC_ASSESSMENT Investigations None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Investigations None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye swollen SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyes watery SYSTEMATIC_ASSESSMENT Eye disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fever (by touch) SYSTEMATIC_ASSESSMENT General disorders None View
Fever (by touch-low grade) SYSTEMATIC_ASSESSMENT General disorders None View
Fever blister SYSTEMATIC_ASSESSMENT General disorders None View
Fever-low grade (by touch) SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flu symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Flush cheeks SYSTEMATIC_ASSESSMENT General disorders None View
Flush, facial SYSTEMATIC_ASSESSMENT General disorders None View
Flushed SYSTEMATIC_ASSESSMENT General disorders None View
Flushed skin SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Foot drop SYSTEMATIC_ASSESSMENT General disorders None View
Gas build-up SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas pains SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized pain SYSTEMATIC_ASSESSMENT General disorders None View
Glands swoll SYSTEMATIC_ASSESSMENT General disorders None View
Glucosuria SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gum line bump (L. upper) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hot feeling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperbilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperthyroid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothyroid SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Impetigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
INC SGOT (serum glutamic oxaloacetic transaminase) SYSTEMATIC_ASSESSMENT Investigations None View
INC SGPT (serum glutamic pyruvic transaminase) SYSTEMATIC_ASSESSMENT Investigations None View
Increase fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Induration injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Inf IV site SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection sclera SYSTEMATIC_ASSESSMENT Eye disorders None View
Injection reaction SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intermittent pain in shaft of R tibia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intermittent H/A (headache) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intermittent cramping legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intermittent fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritable SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching (chest) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching/injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchy L. leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchy scratch under left eye SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Jaw pain SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
L anterior chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Left chest pressure SYSTEMATIC_ASSESSMENT General disorders None View
Left ear ringing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lethargic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Investigations None View
Lips numb SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Loose stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of balance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Low albumin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low CO2 SYSTEMATIC_ASSESSMENT Investigations None View
Low potassium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lower back soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Malleolus (pain) SYSTEMATIC_ASSESSMENT General disorders None View
Minor sore throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle atrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia-bilateral thighs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal drainage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophils SYSTEMATIC_ASSESSMENT Investigations None View
Night sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nose bleed SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nose congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Numbness in feet and hands SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Occipital (mild pain) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain injection site SYSTEMATIC_ASSESSMENT General disorders None View
Pain R foot SYSTEMATIC_ASSESSMENT General disorders None View
Pain R hip SYSTEMATIC_ASSESSMENT General disorders None View
Pain tailbone SYSTEMATIC_ASSESSMENT General disorders None View
Patchy dry skin/itch trunk SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Perior edema SYSTEMATIC_ASSESSMENT General disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Pressure in chest with inhalation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pretib edema SYSTEMATIC_ASSESSMENT General disorders None View
Prickling sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ptosis SYSTEMATIC_ASSESSMENT Eye disorders None View
Puffy face SYSTEMATIC_ASSESSMENT General disorders None View
Quad muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Quad/muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash, chest SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash, arm/chs SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/redness (top of arm) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Runny nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Scrape on face SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scratch under left eye SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Shoulder pain SYSTEMATIC_ASSESSMENT General disorders None View
Skin peeling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Soreness under ribs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Soreness/achiness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiff neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach burning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stuffy nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stye (L) lower corner eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swell ankle SYSTEMATIC_ASSESSMENT General disorders None View
Swell tongue SYSTEMATIC_ASSESSMENT General disorders None View
Swelling lip SYSTEMATIC_ASSESSMENT General disorders None View
Swelling-lower extremity SYSTEMATIC_ASSESSMENT General disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Throat pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tiredness SYSTEMATIC_ASSESSMENT General disorders None View
Ulceration (R) heel SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ulceration L heel SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
URI (upper respiratory infection) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Weakness (L. leg) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Decreased L leg flexibility SYSTEMATIC_ASSESSMENT General disorders None View
Elevated uric acid SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elev phos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Itchy legs SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain, legs SYSTEMATIC_ASSESSMENT General disorders None View
Elevated total bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Achiness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Achy SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne (rash) on chest SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alkaline phosphate elevated SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ALT (SGPT) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
AST (SGOT) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bad taste in mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage sclera SYSTEMATIC_ASSESSMENT Eye disorders None View
Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View