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:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
NCT ID:
NCT02972892
Description:
For each Adverse Event, the following information was recorded: Description of AE, Onset date/time, relationship to device/study, relationship to anesthetic agent, relationship to surgical procedure, resolution, anticipated/unanticipated, serious AE, outcome, severity, and treatment given.
Frequency Threshold:
0
Time Frame:
Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours
Study:
NCT02972892
Study Brief:
Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. | 0 | None | 1 | 104 | 36 | 104 | View |
| Control Arm | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case. | 0 | None | 1 | 116 | 43 | 116 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal Cramps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bladder Spasms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Post-Operative Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Inadvertent Cystotomy and Repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post Operative Pain of 10 | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Intraoperative Bleeding | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Intractable Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pain 7 out of 10 | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Elevated Heart Rate and Breathing | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Bladder Wall Damage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Left Thigh Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain 8 of 10 | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| NIBP SBP>160 mmHg for >5 min | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| NIBP MAP >120 mmHg for > 5 min | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| HR <45bpm more than 5 min | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Emergence Delay | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Throat Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pain 9 of 10 | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Intermittent Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness, photophobia, and delay in discharge from PACU | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Low Urine Output | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Large Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| SpO2 < 90% for more than 5 min | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| NIPB MAP <55 mmHg for >5 min | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| NIBP SBP <70 mmHg for >5 min | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Corneal Abrasion | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hypotension (general) | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Severe Post Operative Pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| HR >110bpm more than 5 min | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |