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 @ 4:06 PM
Ignite Modification Date: 2025-12-25 @ 2:07 PM
NCT ID: NCT00999466
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00999466
Study Brief: The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD8848, 30 μg AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. None None 0 None 6 None View
AZD8848, 60 μg AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. None None 0 None 22 None View
Placebo Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. None None 1 None 24 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tonsillitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASAL MUCOSAL DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
NASAL SEPTUM ULCERATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
UPPER AIRWAY OBSTRUCTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
NASAL DISCOMFORT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
THROAT IRRITATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
NASAL DRYNESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
SNEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
EYE SWELLING SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
GLOSSODYNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
SWOLLEN TONGUE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
ALLERGY TO ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
NASAL VESTIBULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
FACE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
SPUTUM DISCOLOURED SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
NASAL INFLAMMATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View