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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine | Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. | None | None | 12 | 27 | 27 | 27 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neuropathy | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Nervous system disorders | None | View |
| Febrile Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Myalgias/Arthralgias | None | Musculoskeletal and connective tissue disorders | None | View |
| Liver Tests | None | Hepatobiliary disorders | None | View |
| Nail changes | None | Skin and subcutaneous tissue disorders | None | View |
| Stomatitis | None | General disorders | None | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Headache | None | General disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |