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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 0 (PVSRIPO) | A single dose of PVSRIPO into a single lesion. PVSRIPO: Intralesional injection of PVSRIPO. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort 1 (PVSRIPO) | A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines. PVSRIPO: Intralesional injection of PVSRIPO. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort 2 (PVSRIPO) | A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. PVSRIPO: Intralesional injection of PVSRIPO. | 0 | None | 0 | 3 | 3 | 3 | View |
| Cohort 4 (PVSRIPO) | A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter. PVSRIPO: Intralesional injection of PVSRIPO. | 0 | None | 0 | 0 | 0 | 0 | View |
| Cohort 3 (PVSRIPO) | A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. PVSRIPO: Intralesional injection of PVSRIPO. | 0 | None | 0 | 3 | 3 | 3 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| incisional drainage | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 23.1 | View |
| nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| rash macro-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| pruritis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |