Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:34 PM
Ignite Modification Date: 2025-12-25 @ 1:06 PM
NCT ID: NCT00718159
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00718159
Study Brief: Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid 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
Cmax 400 μg/mL (AML) Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. None None 4 4 4 4 View
AUCalb 5500 µg*hr/mL (AML and ET) Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms\*hour per milliliter (µg\*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle. Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg\*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle. None None 6 9 9 9 View
AUCalb 7000 µg*hr/mL (AML) Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg\*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle. None None 1 1 1 1 View
Cmax 250 μg/mL (AML) Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle. None None 3 3 3 3 View
Cmax 300 μg/mL (AML) Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. None None 2 3 3 3 View
Cmax 350 μg/mL (AML) Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. None None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Caecitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Oesophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 14.1 View
Cellulitis orbital SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 14.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 14.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 14.1 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 14.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders 14.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Anal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Inflammatory pain SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Therapeutic response unexpected SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Ulcer SYSTEMATIC_ASSESSMENT General disorders 14.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 14.1 View
Anal infection SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 14.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 14.1 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Blood creatinine SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Fibrin d dimer increased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations 14.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Kyphosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 14.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders 14.1 View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 14.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Subcutaneous nodule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 14.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 14.1 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders 14.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 14.1 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 14.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 14.1 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations 14.1 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 14.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 14.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 14.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View
Blood blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 14.1 View