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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:02 PM
NCT ID: NCT03338556
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT03338556
Study Brief: A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A - PrEP-001 PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001 None None 0 25 19 25 View
Cohort A - Placebo Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo None None 0 27 16 27 View
Cohort B- PrEP-001 PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001 None None 0 24 18 24 View
Cohort B - Placebo Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo None None 0 26 11 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Nervous system disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Headache SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View