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
Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT00394706
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00394706
Study Brief:
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Analyze Early + ITD | Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting. | None | None | 154 | 2310 | 0 | 2310 | View |
| Analyze Early + Sham | Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting. | None | None | 193 | 2321 | 0 | 2321 | View |
| Analyze Early, Not in ITD vs Sham | Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used. | None | None | 122 | 2051 | 0 | 2051 | View |
| Analyze Later + ITD | Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting. | None | None | 166 | 2156 | 0 | 2156 | View |
| Analyze Later + Sham | Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting. | None | None | 174 | 2191 | 0 | 2191 | View |
| Analyze Later, Not in ITD vs. Sham | Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used. | None | None | 121 | 1839 | 0 | 1839 | View |
| Not in AEvAL, ITD Device | Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting. | None | None | 181 | 1336 | 0 | 1336 | View |
| Not in AEvAL, Sham | Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting. | None | None | 152 | 1278 | 0 | 1278 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Airway bleeding | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Defibrillator burns to chest | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Liver lacerations | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
Other Events(If Any):