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: 2025-12-25 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:10 AM
NCT ID: NCT02282605
Description: None
Frequency Threshold: 0
Time Frame: Screening, treatment days 1 and 2 and follow up on days 7 and 14.
Study: NCT02282605
Study Brief: Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
XF-73 2.0 mg/g Nasal Gel 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. XF-73 nasal gel Chlorhexidine gluconate 2% topical cloths None None 0 27 9 27 View
XF-73 0.5 mg/g Nasal Gel 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. XF-73 nasal gel Chlorhexidine gluconate 2% topical cloths None None 0 12 2 12 View
Placebo Nasal Gel 0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. Placebo nasal gel Chlorhexidine gluconate 2% topical cloths None None 0 24 5 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
rhinalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View