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 @ 2:05 AM
Ignite Modification Date: 2025-12-26 @ 12:31 AM
NCT ID: NCT02614560
Description: Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
Frequency Threshold: 5
Time Frame: Up to approximately 1 year
Study: NCT02614560
Study Brief: A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-allo (Before Stem Cell Transplant) Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine) Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2) Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant 6 None 5 6 6 6 View
Post-allo (After Stem Cell Transplant) Post-allo vadastuximab talirine vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle 2 None 2 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Venoocclusive liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.0) View
Graft versus host disease in lung SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.0) View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Venoocclusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (18.0) View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Graft versus host disease in eye SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.0) View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Respirovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Staphylococcus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Bladder hypertrophy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Pulmonary artery wall hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Pulmonary pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View