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 |
|---|---|---|---|---|---|---|---|---|
| Selective T Cell Depletion Transplant Recipients | Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. | None | None | 24 | 31 | 0 | 31 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection with normal absolute nuetrophil count | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with cytomegalovirus reactivation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection with neutropenic fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection cytomegalovirus gastritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| pulmonary infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| renal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| multiple opportunistic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GVHD | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| GVHD/ gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| GVHD/ neurology | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| GVHD/ pulmonary | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| GVHD/ cytomegalovirus reactivation | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Disease progression/ Infection | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Adbdominal mantle cell lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Disease relapse | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| GVHD/ infection | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |