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 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
NCT ID:
NCT00408460
Description:
Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Frequency Threshold:
0
Time Frame:
Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months.
Study:
NCT00408460
Study Brief:
Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Enzyme Inhibitor, Chemotherapy) | Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies | None | None | 14 | 34 | 26 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| CHF exacerbation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Bladder Stone | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Kidney stone | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Foot Drop | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| increased pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |