Adverse Events Module

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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 @ 11:00 AM
Ignite Modification Date: 2025-12-26 @ 11:00 AM
NCT ID: NCT01907906
Description: Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
Frequency Threshold: 0
Time Frame: All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Study: NCT01907906
Study Brief: Inactivation of Whole Blood With Mirasol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mirasol Treated LR-pRBCs derived from Mirasol-treated WB. None None 0 29 11 24 View
Untreated Control LR-pRBCs derived from untreated WB None None 0 29 11 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Infusion site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View