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: 2025-12-24 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT03590366
Description: Beginning with the Screening visit and through the end of study or early termination (ET) visit, the PI and study personnel reviewed each subject's clinical evaluation findings and queried the subject directly regarding AEs. Subjects were to be followed for AEs until 30 days post study conclusion or until the PI determined the AEs were stable, whichever was later. PIs monitored each subject for clinical evidence of adverse events on a routine basis throughout the study.
Frequency Threshold: 0
Time Frame: Baseline to Week 12.
Study: NCT03590366
Study Brief: A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
B244 B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. B244: B244 Suspension 0 None 0 73 19 73 View
Vehicle Vehicle, 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. Vehicle: Vehicle suspension 0 None 0 67 12 67 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Application site pain SYSTEMATIC_ASSESSMENT General disorders None View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders None View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Application site plaque SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View