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 |
|---|---|---|---|---|---|---|---|---|
| Phase 1, Dose Level 1 (10mg/kg) | Phase 1 Dose Level 1: Participants were given a one-time, single-dose administration of oral 10mg/kg Aminolevulinic Acid (5-ALA) | 1 | None | 2 | 3 | 0 | 3 | View |
| Phase 1, Dose Level 2 (20mg/kg) | Phase 1 Dose Level 2: Participants were given a one-time, single-dose administration of oral 20mg/kg Aminolevulinic Acid (5-ALA) | 0 | None | 0 | 3 | 0 | 3 | View |
| Phase 1, Dose Level 3 (30mg/kg) | Phase 1 Dose Level 3: Participants were given a one-time, single-dose administration of oral 30mg/kg Aminolevulinic Acid (5-ALA) | 0 | None | 0 | 3 | 0 | 3 | View |
| Phase 1, Dose Level 4 (40mg/kg) | Phase 1 Dose Level 4: Participants were given a one-time, single-dose administration of oral 40mg/kg Aminolevulinic Acid (5-ALA) | 0 | None | 0 | 4 | 0 | 4 | View |
| Phase 1, Dose Level 5 (50mg/kg) | Phase 1 Dose Level 5: Participants were given a one-time, single-dose administration of oral 50mg/kg Aminolevulinic Acid (5-ALA) | 0 | None | 0 | 6 | 0 | 6 | View |
| Phase 2 (40mg/kg) | Phase 2 Dose (40mg/kg): Participants were given a one-time, single-dose administration of oral 40mg/kg Aminolevulinic Acid (5-ALA) | 0 | None | 2 | 14 | 0 | 14 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| partial seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | non-applicable | View |
| death | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | non-applicable | View |
| scalp wound abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | non-applicable | View |
| severe cerebral edema | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | non-applicable | View |