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: 2025-12-25 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT00241358
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00241358
Study Brief: Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Donors AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3 None None 2 46 46 46 View
Recipients Stem Cell Transplantation Day 0 None None 12 46 46 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Generalized weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Death due to disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Edema - extremities SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (2.0) View
Ankle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
C. Difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Erythemous rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Increased bilirubin SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Increased creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Iron deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Mouth pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Pancytopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Anasarca SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Ankle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Arm pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Bronchospasm wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Cold sensation SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (2.0) View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Distension/abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (2.0) View
Edema/larynx SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Extrapyramidal involuntary movement SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Extremity walking (gait/walking) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Facial edema (head and neck) SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Feet tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Fistula, GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Foliculitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
G-tube site infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Generalized weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Hand tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Heartburn/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Hemoptisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (2.0) View
Interstitial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Lower extremities edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Mental status change SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (2.0) View
Mood alteration SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (2.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Non-specific ST abnormality SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Otitis, middle ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (2.0) View
Paranasal reactions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Petequiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pruritus/itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Shoulder blade pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Spine pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Spine pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Sweating (diaphoresis) SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (2.0) View
Throat pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Thrombosis/embolism (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
U wave SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Urinary color change SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Urinary frequency/urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Vasovagal episode SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Viremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Warm sensation SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Watery eye (tearing) SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View