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 @ 10:07 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT01532635
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01532635
Study Brief: A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Allogeneic HSCT Using Two Related Donors CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28. None None 3 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fevers None General disorders None View
Hypoxia None Blood and lymphatic system disorders None View
Left ventricular systolic dysfunction None Cardiac disorders None View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Hyperbilirubinemia None Blood and lymphatic system disorders None View
Pericardial effusion None Cardiac disorders None View
Dehydration None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None General disorders None View
Anxiety None Psychiatric disorders None View
Arm pain None General disorders None View
Atrial fibrillation None Cardiac disorders None View
Back pain None General disorders None View
Bacteremia None Blood and lymphatic system disorders None View
Balance problems None General disorders None View
Bronchitis None Respiratory, thoracic and mediastinal disorders None View
Change in vision None Eye disorders None View
Chest pain None General disorders None View
Chest tightness None General disorders None View
Chills None General disorders None View
Clostridium difficile None Gastrointestinal disorders None View
CMV reactivation None Immune system disorders None View
Constipation None Gastrointestinal disorders None View
Decreased urine output None Renal and urinary disorders None View
Dehydration None General disorders None View
Depression None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None General disorders None View
Dry eyes None General disorders None View
Dyspepsea None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Dysuria None Renal and urinary disorders None View
Edema None Skin and subcutaneous tissue disorders None View
Electrolyte imbalance None Blood and lymphatic system disorders None View
Fatigue None General disorders None View
Feet pain None General disorders None View
Fevers None General disorders None View
Fluid overload None Blood and lymphatic system disorders None View
Generalized pain None General disorders None View
Generalized weakness None General disorders None View
GVHD rash None Skin and subcutaneous tissue disorders None View
Hand pain None General disorders None View
Headache None General disorders None View
Heartburn None Gastrointestinal disorders None View
Hematuria None Renal and urinary disorders None View
HHV-6 reactivation None Blood and lymphatic system disorders None View
Hiccups None General disorders None View
Hyperbilirubinemia None Blood and lymphatic system disorders None View
Hypertension None Blood and lymphatic system disorders None View
Hypokalemia None Blood and lymphatic system disorders None View
Hyponatremia None Blood and lymphatic system disorders None View
Hypotension None Blood and lymphatic system disorders None View
Hypothermia None General disorders None View
Hypoxia None Blood and lymphatic system disorders None View
Increased alkaline phosphatase None General disorders None View
Increased creatinine None Blood and lymphatic system disorders None View
Increased LFTs None Hepatobiliary disorders None View
Knee pain None General disorders None View
Leg pain None General disorders None View
Malnutrition None Metabolism and nutrition disorders None View
Mental status change None Psychiatric disorders None View
Mucositis None Gastrointestinal disorders None View
Neck pain None General disorders None View
Nocturia None Renal and urinary disorders None View
Orthostatic hypotension None Blood and lymphatic system disorders None View
Osteopenia None Musculoskeletal and connective tissue disorders None View
Parotitis None General disorders None View
Platelet transfusion reaction None Blood and lymphatic system disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Rectal pain None General disorders None View
Rigors None General disorders None View
Shoulder pain None General disorders None View
Swollen ankles None General disorders None View
Tachycardia None Cardiac disorders None View
Tachypnea None Respiratory, thoracic and mediastinal disorders None View
Toenail bleeding None General disorders None View
Trouble sleeping None General disorders None View
Upper extremity swelling None General disorders None View
Urinary retention None Renal and urinary disorders None View
Vaginal discomfort/itching None General disorders None View
Volume overload None Cardiac disorders None View
Weight loss None General disorders None View