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 |
|---|---|---|---|---|---|---|---|---|
| Control (= no Intervention Arm). | Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs). | 0 | None | 1 | 24 | 20 | 24 | View |
| Raltegravir Arm. | Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs). Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component . | 0 | None | 0 | 19 | 16 | 19 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastrointestinal (diarrhoea, nausea) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Sleeping difficulties | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dizzyness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |