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 |
|---|---|---|---|---|---|---|---|---|
| E (Cohort 4) | Participants with DFU were administered a single dose of 1 percent of 100 mg/cm\^2 GSK1278863 on wounded skin. | 0 | None | 1 | 3 | 1 | 3 | View |
| Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | 0 | None | 0 | 4 | 1 | 4 | View |
| D (Cohort 3) | Participants with DFU were administered a single dose of 1 percent of 25 mg/cm\^2 GSK1278863 on wounded skin. | 0 | None | 0 | 5 | 0 | 5 | View |
| A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | 0 | None | 0 | 9 | 2 | 9 | View |
| Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | 0 | None | 0 | 3 | 1 | 3 | View |
| C (Cohort 2) | Participants with DFU were a single dose of 0.1 percent of 25 mg/cm\^2 GSK1278863 on wounded skin. | 0 | None | 0 | 5 | 0 | 5 | View |
| Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | 0 | None | 1 | 4 | 1 | 4 | View |
| R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm\^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | 0 | None | 0 | 26 | 0 | 26 | View |
| Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. | 0 | None | 1 | 4 | 1 | 4 | View |
Serious Events
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infected skin ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |