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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 (RS < 11) | Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System * Hormonal therapy: * Tamoxifen Citrate (pre-menopausal women) OR * Aromatase Inhibition Therapy (post-menopausal women) | None | None | 0 | 0 | 0 | 0 | View |
| Group 2 Arm 1 (RS 11-25) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System * Hormonal therapy: * Tamoxifen Citrate (pre-menopausal women) OR * Aromatase Inhibition Therapy (post-menopausal women) | None | None | 0 | 0 | 0 | 0 | View |
| Group 2 Arm 2 (RS 11-25) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/Oncotype DX Gene Expression Profiling System * Systemic chemotherapy | None | None | 0 | 0 | 0 | 0 | View |
| Group 3 (RS > 25) | Patients with a high RS (\> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/Oncotype DX Gene Expression Profiling System * Systemic chemotherapy | None | None | 0 | 0 | 0 | 0 | View |