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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT02971293
Description: All reported AEs, date of onset, date of resolution, Investigator's assessment of severity, outcome, action taken with IP, and relationship to the IP were listed. Non-Treatment-emergent adverse event (non-TEAE): any AE occurring before the first dose of IP, or \>30 days after the last dose TEAE: event occurring after first dose of IP or present prior to the first dose, but increasing in severity after IP administration.
Frequency Threshold: 5
Time Frame: From screening to Follow-up/early termination Visit, 28 to 35 days after the last administration of investigational product (IP)
Study: NCT02971293
Study Brief: Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD8871 100 µg The subjects received AZD8871 100 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products. 0 None 0 34 5 34 View
AZD8871 600 µg The subjects received AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products. 0 None 1 39 7 39 View
Placebo The placebo was administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient received one inhaled dose from placebo DPI provided to him/her on each day of the treatment period. 0 None 1 36 5 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal wall abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Chronic obstructive pulmonary disease exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 20.0 View
Viral upper respiratory tract infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View