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: 2025-12-25 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:04 AM
NCT ID: NCT04081220
Description: AEs are assessed through regular investigator assessments and laboratory testing.
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT04081220
Study Brief: Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IMG-7289 IMG-7289: Single starting dose with individualized dose titrations throughout 1 None 1 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Uterine Cramp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Increased red blood cells SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Periorbital infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
COVID 19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bursitis Left Shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abscess cheek SYSTEMATIC_ASSESSMENT Infections and infestations None View
Low Back Spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperkalemia 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