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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT01630135
Description: Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.
Frequency Threshold: 0
Time Frame: Participants were analyzed from the start of study treatment until the follow up contact (up to 3 weeks).
Study: NCT01630135
Study Brief: Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluticasone Furoate 55 µg Per Day Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks. None None 0 131 23 131 View
Placebo Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks. None None 0 130 25 130 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 15.0 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, version 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Heat illness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA, version 15.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 15.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 15.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 15.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA, version 15.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA, version 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 15.0 View
Orthostatic intolerance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, version 15.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA, version 15.0 View
Heat rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA, version 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA, version 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 15.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA, version 15.0 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA, version 15.0 View