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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT01560234
Description: None
Frequency Threshold: 0
Time Frame: Screening up to 11 - 13 Months
Study: NCT01560234
Study Brief: AZD8848 Single Ascending Dose Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 AZD8848 0.15 μg None None 0 4 2 4 View
Cohort 2 AZD8848 0.5 ug None None 0 4 1 4 View
Cohort 3 AZD8848 1.5 μg None None 0 3 0 3 View
Cohort 4 AZD8848 5 μg None None 1 4 3 4 View
Cohort 5 AZD8848 15 μg None None 0 4 1 4 View
Cohort 6 and 8 AZD8848 30 μg (similar investigational product administration conditions) None None 0 4 4 8 View
Placebo Commercial 0.9% sodium chloride solution. None None 0 16 6 16 View
Cohort 7 AZD8848 15 μg (Multiple Inhalation) None None 0 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pelvic Inflammatory disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
chills SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Upper respiratory tract infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 15.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.1 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 15.1 View
dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 15.1 View