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 |
|---|---|---|---|---|---|---|---|---|
| PCLX-001 Intervention 40mg | Cohort 2: Participants were administered 40mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 1 | None | 1 | 3 | 0 | 3 | View |
| PCLX-001 Intervention 70mg | Cohort 3: Participants were administered 70mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 1 | None | 1 | 3 | 0 | 3 | View |
| PCLX-001 Intervention 100mg | Cohort 4: Participants were administered 100mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 1 | None | 1 | 6 | 0 | 6 | View |
| PCLX-001 Intervention 140mg | Cohort 5: Participants were administered 140mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 0 | None | 0 | 3 | 0 | 3 | View |
| PCLX-001 Intervention 210mg | Cohort 6: Participants were administered 210mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 0 | None | 0 | 8 | 0 | 8 | View |
| PCLX-001 Intervention 280mg | Cohort 7: Participants were administered 280mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 0 | None | 3 | 3 | 0 | 3 | View |
| PCLX-001 Intervention 20mg | Cohort 1: Participants were administered 20mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle. | 0 | None | 0 | 3 | 0 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroduodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| COVID 19 | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shortness of Breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hepatobiliary Disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |