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 @ 10:54 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT01522469
Description: Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.
Frequency Threshold: 0
Time Frame: From date of first dose up to 30-days after the last dose, 1 year.
Study: NCT01522469
Study Brief: Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Patients Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission. 13 None 12 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute febrile neutrophilic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lip ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral mucosal blistering SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Face oedema SYSTEMATIC_ASSESSMENT General disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Multi-organ disorder SYSTEMATIC_ASSESSMENT General disorders None View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alpha hemolytic streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory synctial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphlococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood urea nitrogen/creatinine ratio SYSTEMATIC_ASSESSMENT Investigations None View
Blood urea nitrogen/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyl transferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Monocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoproteinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chondrocalcinosis pyrophosphate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulval disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute febrile neutrophilic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair color changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Madarosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngeal ulceration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ocular icterus SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View