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 |
|---|---|---|---|---|---|---|---|---|
| IM of CYP2C19 | CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (\*2 and \*3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test. \[13C\]Pantoprazole: \[13C\]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes | None | None | 0 | 10 | 0 | 10 | View |
| EM of CYP2C19 | CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19\*1/\*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test. \[13C\]Pantoprazole: \[13C\]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes | None | None | 0 | 10 | 0 | 10 | View |
| PM of CYP2C19 | Homozygous for CYP2C19 null alleles (\*2/\*2, \*2/\*3 or \*3/\*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test. \[13C\]Pantoprazole: \[13C\]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes | None | None | 0 | 5 | 0 | 5 | View |