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 |
|---|---|---|---|---|---|---|---|---|
| Phase I: Intervention | In Phase I of the study, bortezomib will be administered in 4 dose cohorts: .8 mg/m2 , 1.0 mg/m2, 1.3 mg/m2, and1.5 mg/m2. Three patients will be accrued in each dose cohort with enrollment starting at dose cohort 1 (.8 mg/m2). Bortezomib will be given on days -11,-8, -5, and -2. All study patients will receive BEAM conditioning per our standard institution protocol: carmustine (BCNU) 300 mg/m2 on day -5,etoposide 100 mg/m2 twice daily on days -5, -4, -3, and -2, cyatabine100 mg/m2 twice daily on days -5, -4, -3, and -2, and melphalan 140 mg/m2 on day -1 before infusion of autologous stem cells. The objective of phase I is to determine the maximum tolerated dose (MTD) of bortezomib in this setting. After the MTD is defined, another 20 patients will be enrolled in the Phase II portion of this protocol to obtain a preliminary estimate of the response rate. | None | None | 0 | 13 | 13 | 13 | View |
| Phase II: Survival | Patients enrolled to obtain a preliminary estimate of ORR, Progression-free survival, and overall survival (OS) using this regimen. | None | None | 1 | 29 | 29 | 29 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| adynamic ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenic Fever | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Peripheral Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Vasovagal syncope/orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |