Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT06122935
Description: For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events. Adverse event data were monitored and assessed per procedure, rather than at the participant level.
Frequency Threshold: 0
Time Frame: Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).
Study: NCT06122935
Study Brief: Evaluation of the Aurora Xi New Nomogram Software 2.0
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Group Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System Aurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor. 0 None 0 26351 338 26351 View
Control Group Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System Aurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System 0 None 0 26117 309 26117 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
IQPP 1.1 Hypotensive, Prefaint, No LOC (Minor) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 1.2 Hypotensive, Prefaint, No LOC (Moderate) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 1.3 Hypotensive, LOC (brief) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 1.4 Hypotensive, LOC (prolonged) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 1.5 Hypotensive, Severe (With or Without LOC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 1.6 Hypotensive, Injury SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IQPP 3. Local Injury Related to Phlebotomy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
IQPP 4. Citrate Reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
IQPP 7.1 Allergic, Local SYSTEMATIC_ASSESSMENT General disorders None View
IQPP 8. Hyperventilation SYSTEMATIC_ASSESSMENT General disorders None View
IQPP 9. Other SYSTEMATIC_ASSESSMENT General disorders None View