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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT02479412
Description: None
Frequency Threshold: 0
Time Frame: From Screening to Follow-up (these two examinations are up to 165 days apart)
Study: NCT02479412
Study Brief: A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
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 (PBO) Placebo for AZD7594 DPI once daily None None 0 52 17 52 View
AZD7594 58 μg AZD7594 DPI once daily - 2 capsules of 29 μg None None 0 34 13 34 View
AZD7594 250 μg AZD7594 DPI once daily - 2 capsules of 125 μg None None 0 34 9 34 View
AZD7594 800 μg AZD7594 DPI once daily - 2 capsules of 400 μg None None 0 34 12 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Sputum increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Nasal inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.1. View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.1. View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.1. View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 18.1. View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 18.1. View
Hepatosplenomegaly NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 18.1. View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.1. View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.1. View
Anaemia vitamin B12 deficiency NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 18.1. View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 18.1. View