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: 2025-12-25 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT03198234
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded up to 1 year post-transplant.
Study: NCT03198234
Study Brief: Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 Participants receive 1 X 10\^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant). 0 None 3 3 3 3 View
Cohort 2 Participants receive 3 X 10\^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant). 1 None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Duodenal hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (Unspecified) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: RSV SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
AML relapse SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (Unspecified) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (Unspecified) View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (Unspecified) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Cramps in legs (with bowel movement) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Cushingoid appearance SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (Unspecified) View
D-dimer increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (Unspecified) View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Elevated procalcitonin SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Enterocolitis infectious (C.difficile) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Erythema (hairline) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (Unspecified) View
Eyelid swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (Unspecified) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Flattened affect NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (Unspecified) View
Flushed face NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (Unspecified) View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Gum swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
GVHD: Chronic eyes SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
GVHD: Chronic GI SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
GVHD: Chronic Liver SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
GVHD: Chronic skin SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
GVHD: Acute GI SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
GVHD: Acute skin SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (Unspecified) View
Haptoglobin decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
High Blood Urea Nitrogen (BUN) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hyperchloremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (Unspecified) View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypoproteinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (Unspecified) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Increased GGT SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Increased LDH SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Infusion-related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
International normalized ratio (INR) increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (Unspecified) View
Intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Jaw pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Lip lesion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Low bicarbonate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Mild sensitivity to spicy foods NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Pain: generalized NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Pain: gingival NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Pain: neuropathic NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Pain: pelvic NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Pain: perianal NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Papulopustular rash (face) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (Unspecified) View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (Unspecified) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Positive occult blood NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Acneform (body) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Acneform (face) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Erythematous, lacy (extremities) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Erythematous, lacy (trunk) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Impetigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Maculo-papular (body) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rash: Maculo-papular (face) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Redman syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Shoulder pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Skin infection (Staphylococcus aureus) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Skin redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Striae on arms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Striae on legs SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Striae on trunk SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Systolic murmur SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Total lung capacity decreased SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Upper airway congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: Adenovirus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: Adenovirus (stool) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: CMV SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: CMV (bone marrow) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: CMV (intestine) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: EBV SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: HHV6 SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Viremia: Parvovirus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Watering eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (Unspecified) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Wound infection (MSSA) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (Unspecified) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (Unspecified) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (Unspecified) View
Aspartate aminotransferase increased (AST) SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Blood in stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Body aches NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Breakthrough bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (Unspecified) View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Alanine aminotransferase increased (ALT) SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (Unspecified) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (Unspecified) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View