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 @ 7:30 PM
Ignite Modification Date: 2025-12-25 @ 5:12 PM
NCT ID: NCT01214603
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01214603
Study Brief: A Study in Participants With Acute Leukemia
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, 40 mg LY2090314: D1, D8, D15 LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. None None 4 7 7 7 View
Cohort 2, 40 mg LY2090314: D1, D5, D9 LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. None None 5 6 6 6 View
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12 LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles. If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met. None None 6 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cardiac ventricular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Halo vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Retinal exudates SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gingival blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View