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 @ 3:54 PM

Ignite Modification Date: 2025-12-25 @ 1:59 PM

NCT ID: NCT00788892

Description: The Safety Analysis Set included subjects receiving at least 1 dose of study drug and consisted of 126 subjects.

Frequency Threshold: 5

Time Frame: Assessed during treatment period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)

Study: NCT00788892

Study Brief: Trial of CPX-351 in Newly Diagnosed Elderly 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

Arm A: CPX-351	First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3	None	None	47	85	85	85	View
Arm B: Cytarabine + Daunorubicin	First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice	None	None	16	41	41	41	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	None	Blood and lymphatic system disorders	None	View
Febrile Neutropenia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Acute Myocardial Infarction	None	Cardiac disorders	None	View
Angina Pectoris	None	Cardiac disorders	None	View
Atrial Fibrillation	None	Cardiac disorders	None	View
Cardiac Arrest	None	Cardiac disorders	None	View
Cardiac Failure Congestive	None	Cardiac disorders	None	View
Myocardial Infarction	None	Cardiac disorders	None	View
Restrictive Cardiomyopathy	None	Cardiac disorders	None	View
Supraventricular Tachycardia	None	Cardiac disorders	None	View
Blindness	None	Eye disorders	None	View
Abdominal Pain	None	Gastrointestinal disorders	None	View
Gastrointestinal Necrosis	None	Gastrointestinal disorders	None	View
Ileal Perforation	None	Gastrointestinal disorders	None	View
Mouth Haemorrhage	None	Eye disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Small Intestinal Obstruction	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Disease Progression	None	General disorders	None	View
Infusion Related Reaction	None	General disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Hyperbilirubinaemia	None	Hepatobiliary disorders	None	View
Graft Versus Host Disease	None	Immune system disorders	None	View
Bacteraemia	None	Infections and infestations	None	View
Catheter Site Cellulitis	None	Infections and infestations	None	View
Catheter Site Infection	None	Infections and infestations	None	View
Cellulitis	None	Infections and infestations	None	View
Clostridium Difficile Colitis	None	Infections and infestations	None	View
Device Related Sepsis	None	Infections and infestations	None	View
Fungal Infection	None	Infections and infestations	None	View
Fungal Retinitis	None	Infections and infestations	None	View
Fungal Skin Infection	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Pneumonia Fungal	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Septic Shock	None	Infections and infestations	None	View
System Mycosis	None	Infections and infestations	None	View
Urinary Tract Infection	None	Infections and infestations	None	View
Brain Herniation	None	Injury, poisoning and procedural complications	None	View
Hip Fracture	None	Injury, poisoning and procedural complications	None	View
Blood Creatinine Increased	None	Investigations	None	View
Acute Myeloid Leukaemia	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Leukaemia Recurrent	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Malignant Melanoma In Situ	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Convulsion	None	Nervous system disorders	None	View
Haemorrhage Intracranial	None	Nervous system disorders	None	View
Subarachnoid Haemorrhage	None	Nervous system disorders	None	View
Syncope	None	Nervous system disorders	None	View
Mental Status Changes	None	Psychiatric disorders	None	View
Psychotic Disorder	None	Psychiatric disorders	None	View
Nephrogenic Diabetes Insipidus	None	Renal and urinary disorders	None	View
Renal Failure	None	Renal and urinary disorders	None	View
Renal Failure Acute	None	Renal and urinary disorders	None	View
Acute Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Non-Cardiogenic Pulmonary Oedema	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Oedema	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Arrest	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Distress	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Tract Haemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Stevens-Johnson Syndrome	None	Skin and subcutaneous tissue disorders	None	View
Hypotension	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Febrile Neutropenia	None	Blood and lymphatic system disorders	None	View
Neutropenia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Angina Pectoris	None	Cardiac disorders	None	View
Atrial Fibrillation	None	Cardiac disorders	None	View
Bradycardia	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Conjunctivitis	None	Eye disorders	None	View
Abdominal Distension	None	Gastrointestinal disorders	None	View
Abdominal Pain	None	Gastrointestinal disorders	None	View
Abdominal Pain Upper	None	Gastrointestinal disorders	None	View
Ascites	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Dry Mouth	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Haemorrhoids	None	Gastrointestinal disorders	None	View
Mouth Haemorrhage	None	Gastrointestinal disorders	None	View
Mouth Ulceration	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Oral Disorder	None	Gastrointestinal disorders	None	View
Oral Pain	None	Gastrointestinal disorders	None	View
Stomatitis	None	Gastrointestinal disorders	None	View
Toothache	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Asthenia	None	General disorders	None	View
Catheter SIte Erythema	None	General disorders	None	View
Catheter Site Pain	None	General disorders	None	View
Chills	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Gait Disturbance	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Oedema	None	General disorders	None	View
Hyperbilirubinaemia	None	Hepatobiliary disorders	None	View
Drug Hypersensitivity	None	Immune system disorders	None	View
Bacteraemia	None	Infections and infestations	None	View
Catheter Site Infection	None	Infections and infestations	None	View
Cellulitis	None	Infections and infestations	None	View
Clostridium difficile infection	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Transfusion Reaction	None	Injury, poisoning and procedural complications	None	View
Blood Alkaline Phosphate Increased	None	Investigations	None	View
Blood Creatinine Increased	None	Investigations	None	View
Breath Sounds Abnormal	None	Investigations	None	View
Cardiac Murmur	None	Investigations	None	View
Weight Decreased	None	Investigations	None	View
Dizziness	None	Nervous system disorders	None	View
Dysgeusia	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Lethargy	None	Nervous system disorders	None	View
Somnolence	None	Nervous system disorders	None	View
Syncope	None	Nervous system disorders	None	View
Tremor	None	Nervous system disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Confusional State	None	Psychiatric disorders	None	View
Depression	None	Psychiatric disorders	None	View
Hallucination	None	Psychiatric disorders	None	View
Insomnia	None	Psychiatric disorders	None	View
Mental Status Change	None	Psychiatric disorders	None	View
Haematuria	None	Renal and urinary disorders	None	View
Pollakiuria	None	Renal and urinary disorders	None	View
Renal Failure	None	Renal and urinary disorders	None	View
Renal Failure Acute	None	Renal and urinary disorders	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea Exertional	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Haemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
Hiccups	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Nasal Congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
Oropharyngeal Pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural Effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Rales	None	Respiratory, thoracic and mediastinal disorders	None	View
Tachypnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	None	Skin and subcutaneous tissue disorders	None	View
Dry Skin	None	Skin and subcutaneous tissue disorders	None	View
Ecchymosis	None	Skin and subcutaneous tissue disorders	None	View
Erythema	None	Skin and subcutaneous tissue disorders	None	View
Hyperhidrosis	None	Skin and subcutaneous tissue disorders	None	View
Night Sweats	None	Skin and subcutaneous tissue disorders	None	View
Petechiae	None	Skin and subcutaneous tissue disorders	None	View
Pruritus	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Skin Lesion	None	Skin and subcutaneous tissue disorders	None	View
Hypertension	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Increased tendency to bruise	None	Blood and lymphatic system disorders	None	View
Gingival bleeding	None	Gastrointestinal disorders	None	View
Melaena	None	Gastrointestinal disorders	None	View
Proctalgia	None	Gastrointestinal disorders	None	View
Chest pain	None	General disorders	None	View
Bacterial disease carrier	None	Infections and infestations	None	View
Enterococcal bacteraemia	None	Infections and infestations	None	View
Staphylococcal bacteraemia	None	Infections and infestations	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal pain	None	Musculoskeletal and connective tissue disorders	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Pain in jaw	None	Musculoskeletal and connective tissue disorders	None	View
Purpura	None	Skin and subcutaneous tissue disorders	None	View
Rash erythematous	None	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	None	Skin and subcutaneous tissue disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Weight Increased	None	Investigations	None	View
Decreased Appetite	None	Metabolism and nutrition disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Fluid Overload	None	Metabolism and nutrition disorders	None	View
Hyperglycaemia	None	Metabolism and nutrition disorders	None	View
Hypokalaemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	None	Metabolism and nutrition disorders	None	View
Hyponatraemia	None	Metabolism and nutrition disorders	None	View
Hypophosphataemia	None	Metabolism and nutrition disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Muscular Weakness	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Dysphonia	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Hypertension	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Oedema	None	Respiratory, thoracic and mediastinal disorders	None	View