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
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
NCT ID:
NCT00594932
Description:
Definitions do not differ. However we only collected accurate non-serious adverse events for the first three months. After that it was no longer a blinded trial, those who wanted to continue were receiving MMF, a standard of care for SLE. Safety of this commonly used drug would not be interpretable in a tiny trial after the double blind period. However, we can report SAEs for six months, since we are confident we can be accurate about those. There were also no deaths over six months.
Frequency Threshold:
5
Time Frame:
3 months for non serious adverse events and six months for deaths and serious adverse events. We did not formally collect adverse events after the end of the double blind part of the study since all continuing patients received open lable MMF, a standard of care for SLE. Since we are confident that there were no additional deaths or serious adverse events over six months, we can report those for the entire six month period but we only have non serious adverse events collected for three months.
Study:
NCT00594932
Study Brief:
Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mycophenolate Mofetil | Patients receiving mycophenolate mofetil from baseline throughout their participation in the study (up to six months). Mycophenolate is a standard of care treatment for SLE, and the primary endpoint was at three months, after which mycophenolate was given "open lable." This trial did not collect adverse events after three months in any formal manner that can be reported here. However there were no deaths so we can report that for six months. We can also report serious adverse events for all six months. Therefore deaths and serious adverse events are reported for six months and placebo crossovers are included in the "at risk" population for a total of 24 at risk. However non serious adverse events can only be reported for three months so the population at risk remains at 13 for non serious adverse events. | 0 | None | 2 | 24 | 12 | 13 | View |
| Placebo | Patients receiving placebo for the first three months. They were then offered mycophenolate mofetil for up to three more months. Since this is a standard of care for SLE formal assessment of adverse events was not performed during the second three months. We cannot provide any data after the first three months on placebo patients since there were no placebo patients after the first three months. Therefore the at risk population on placebo is 14 and the reporting period is 3 months for them. This is true for all types of adverse events since there was no placebo group after 3 months. | 0 | None | 2 | 14 | 12 | 14 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| avascular necrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| upper GI bleed | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| groin abcess | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| mild to moderate infection (includes respiratory tract, urinary tract, vaginitis, non serious abcess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Other mild or moderate AEs | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Renal Stones | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |