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 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT04071366
Description: Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
Frequency Threshold: 5
Time Frame: TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Study: NCT04071366
Study Brief: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1: Itacitinib 200 mg QD + Tecartus Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26). 2 None 1 12 12 12 View
Part 1: Itacitinib 200 mg QD + Yescarta Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26). 9 None 9 35 35 35 View
Part 1: Itacitinib 200 mg + Any IEC Participants being treated with Kymriah, Yescarta, and Tecartus (Day 0; per prescribing information), IEC therapies for hematologic malignancies, received itacitinib 200 mg once daily for 30 days (Day -3 to Day 26). 15 None 12 63 63 63 View
Part 2: Itacitinib 200 mg BID + Yescarta Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26). 2 None 3 23 22 23 View
Part 2: Placebo BID + Yescarta Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26). 2 None 6 24 24 24 View
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26). 4 None 2 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Pneumonia necrotising SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Sinusitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
VIth nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Bronchopleural fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Fusarium infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Immune effector cell-associated neurotoxicity syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26 View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Anal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Cytomegalovirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Delirium febrile SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Disorganised speech SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 26 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Fluid intake reduced SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Gastroenteritis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Penile ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Polyomavirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26 View
Sensitive skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26 View