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 @ 11:50 AM
Ignite Modification Date: 2025-12-26 @ 10:21 AM
NCT ID: NCT00989261
Description: Of note, AML disease progression (which includes the verbatim terms of progressive disease, disease progression, and relapsed AML) is reported as an AE in the data output and in the in-text tables; however, it is not considered an AE because of the population under study and is not further discussed.
Frequency Threshold: 5
Time Frame: Adverse event (AE) data was collected after the first dose of study drug through 30 days after the last dose of study drug, approximately 5 years.
Study: NCT00989261
Study Brief: Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
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; ≥60 Years of Age FLT3-ITD positive and negative populations will be divided into 2 cohorts as follows: Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day. 71 None 134 157 151 157 View
Cohort 2; ≥18 Years of Age Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day. 60 None 135 176 175 176 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Acute myeloid leukemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Leukemic infiltration brain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Lymphohistiocytosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Myelofibrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Non-Hodgkin's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Accidental poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Subdural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Troponin T increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary alveolar hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Intraventricular hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Postictal state SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Barrett's esophagus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Ileitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Mouth hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal tubular disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Acute febrile neutrophilic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Toxic skin eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle hemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Abscess neck SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Acinetobacter bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Breast cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cellulitis orbital SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Enterobacter bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Enterobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Escherichia bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Klebsiella bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lower respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Necrotizing fascitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pericoronitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pseudomonal bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Staphylococcal bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vulval abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vulval cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Serratia bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sinusitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Acute promyelocytic leukemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Hair color changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Mouth hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Alanine aminotransferse increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View