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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
NCT ID:
NCT00041067
Description:
Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
Frequency Threshold:
5
Time Frame:
Every 3 weeks for up to 3 years.
Study:
NCT00041067
Study Brief:
S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast 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 |
|---|---|---|---|---|---|---|---|---|
| Docetaxel + Vinorelbine + G-CSF + Trastuzumab | None | None | None | 0 | 73 | 71 | 73 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| LVEF decrease/CHF | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Eye-other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Tearing | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Abdominal pain/cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Constipation/bowel obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fatigue/malaise/lethargy | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever without neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain-other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Infection w/o 3-4 neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Alkaline phosphatase increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Bilirubin increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Neutropenia/granulocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| SGOT (AST) increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| SGPT (ALT) increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Chest pain,not cardio or pleur | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Muscle weakness (not neuro) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Dizziness/light headedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neuropathic pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Taste disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Anxiety/agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pneumonitis/infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |