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 @ 1:13 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT02730195
Description: None
Frequency Threshold: 0
Time Frame: Up to 30 days after the end of treatment
Study: NCT02730195
Study Brief: Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic 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
Pioglitazone & TKI Therapy Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy 0 None 0 9 7 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema face NON_SYSTEMATIC_ASSESSMENT General disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine discoloration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Irregular menstruation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nipple tenderness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View