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 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
NCT ID:
NCT00787267
Description:
None
Frequency Threshold:
4
Time Frame:
None
Study:
NCT00787267
Study Brief:
Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Evalulable Patients That Received Dasatinib | Dasatinib: 70 mg PO twice daily until progression. | None | None | 17 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| dehydration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hyponatremia - metabolic/lab | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| muscle weakness (generalized) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| neuro-motor (generalized weakness) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| pericardial effusion | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| decreased leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| anorexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| decreased hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anorexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| bronchospasm (wheezing) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| decreased hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| decreased neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| dizziness (lightheadedness) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| edema (periorbital/face) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| elevated AST | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| elevated creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| elevated LDH | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| hair loss (alopecia) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| leukocytosis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| muscle weakness - lower extremity (leg weakness) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| muscle weakness (generalized) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| myalgias (generalized) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| neutrophils (neutropenia) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| pain extremity (legs) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| pain-joint | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| pedal edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| pleural effusion, bilateral | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| pulmonary edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| renal/genitourinary other (slow starting urinary stream) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| taste alteration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| ulcers (scrotal) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| weight loss | SYSTEMATIC_ASSESSMENT | General disorders | None | View |