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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT00539994
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00539994
Study Brief: Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo 200 mg BID for 5 days None None 0 15 5 15 View
Retapamulin 5 Days Retapamulin ointment, 1% 200 mg BID 5 days None None 1 19 10 19 View
Retapamulin 3 Days Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days None None 0 23 6 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Burning Sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Paraesthesia None Nervous system disorders None View
Asthenia None General disorders None View
Ill-defined disorder None General disorders None View
Rhinitis None Infections and infestations None View
Viral infection None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Post procedural complication None Injury, poisoning and procedural complications None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Dermatitis allergic None Skin and subcutaneous tissue disorders None View
Pruritus allergic None Skin and subcutaneous tissue disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Lymphadenopathy None Blood and lymphatic system disorders None View
Palpitations None Cardiac disorders None View
Blepharitis None Eye disorders None View
Gastrooesophageal reflux disease None Gastrointestinal disorders None View