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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT04115059
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected after dasatinib initiation, through 30 days after the last dose of dasatinib (e.g. 6 months). Participants were observed for overall survival for up to 2 years, or until withdrawal of consent or death.
Study: NCT04115059
Study Brief: Dasatinib In Waldenström Macroglobulinemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dasatinib \-- After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. Dasatinib: Oral Study Drug(s): * Each study treatment cycle lasts 4 weeks during which time you will be taking the study drug one time per day. * This will continue for up to 24 cycles. Dasatinib: Oral, daily, dosing per protocol, once a day for cycle 1 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metapneumovirus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mouth sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fluid overload SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Leg edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Withdrawal symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Body Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Migraines SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Post nasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View