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 |
|---|---|---|---|---|---|---|---|---|
| Nebulised Recombinant Tissue-Plasminogen Activator (Rt-PA) - Cohort 1 | Patients in the rt-PA group received the first dose as soon as possible after registration. Initial dosing regime: 10 mg of rt-PA dissolved in 5 ml of diluent given every 6 hrs (resulting in a total daily dose of 40mg) for a maximum of 66 hrs, in addition to standard of care for COVID-19 acute respiratory distress syndrome (ARDS). Following a protocol amendment, dosing duration was increased from 3 days to up to 14 days of rt-PA treatment. Six patients were receiving Invasive mechanical ventilation and 3 were receiving non-invasive ventilation. | 1 | None | 0 | 9 | 4 | 9 | View |
| Historical Matched Controls - Cohort 1 | Historical matched controls were recruited at a ratio of 2 controls to every 1 rtPA + SOC arm patient, and were matched according to the following characteristics: 1. Ventilation and oxygen type (IMV and non-invasive oxygen support) 2. Severity as determined by PaO2/FiO2 ratio 3. Gender 4. Age (+/- 2 years, up to a maximum of 10 years) 5. Ethnicity | 10 | None | 0 | 0 | 0 | 0 | View |
| Nebulised Recombinant Tissue-Plasminogen Activator (Rt-PA) - Cohort 2 IMV | In cohort 2, fewer timepoints were collected, which will allowed for more rapid recruitment while at the same time not compromising safety monitoring. A more flexible dosing regimen for rtPA was utilised. Patients on IMV received 60mg daily over three doses for up to 14 days | 5 | None | 1 | 12 | 9 | 12 | View |
| Nebulised Recombinant Tissue-Plasminogen Activator (Rt-PA) - Cohort 2 NIV | In cohort 2, fewer timepoints were collected, which will allowed for more rapid recruitment while at the same time not compromising safety monitoring. A more flexible dosing regimen for rtPA was utilised. Patients on NIV received 60mg daily for over 3 doses for two days, followed by 12 days receiving 40mg daily over two doses. | 3 | None | 0 | 14 | 4 | 14 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerebral bleed | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bleed: Central venous catheters access site | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Gastro-intestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Blood-stained tracheobronchial secretion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Tracheostomy site bleed | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Bleed: chest-drain related | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |