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 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
NCT ID:
NCT00169104
Description:
None
Frequency Threshold:
5
Time Frame:
14 weeks
Study:
NCT00169104
Study Brief:
Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| G-CSF | Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14. G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14 trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14 vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13 G-CSF: 5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study | 0 | None | 1 | 11 | 10 | 11 | View |
| {Placebo | Subjects will receive ten doses of a placebo injection SQ daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14. G-CSF: 5 mcgm/kg daily Monday through Friday weeks 3-14 trastuzumab: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14 vinorelbine: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13 saline placebo: Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study | 0 | None | 1 | 8 | 6 | 8 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Arthralgias | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Granulocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Granulocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Granulocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Elevated alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Elevated alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Elevated AST | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Elevated AST | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Elevated ALT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |