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
| 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 |
| 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 |
| 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 |