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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT03645434
Description: An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition might be symptoms, signs or the abnormal results of an investigation. The safety population was defined as all randomized patients who took at least one dose of IMP.
Frequency Threshold: 5
Time Frame: AEs starting on or after the first administration of study treatment, up to and including 42 days after the last dose of study treatment.
Study: NCT03645434
Study Brief: A Single Inhalation Dose Study to Assess Efficacy, Pharmacokinetics (PK), Safety and Tolerability of AZD8871 in Patients With Long-term Lung Diseases.
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 Subjects received AZD8871 (as saccharinate) inhalation powder 600 μg, orally 1 inhalation per day in treatment period 1 under sequences A and B; treatment period 2 under sequences C and E; and treatment period 3 under sequences D and F. 0 None 0 70 19 70 View
Anoro® Ellipta® Subjects received Anoro® Ellipta® (umeclidinium / vilanterol) 55 μg / 22 μg orally 1 inhalation per day in treatment period 1 under sequences C and D; treatment period 2 under sequences A and F; and treatment period 3 under sequences B and E. 0 None 2 69 19 69 View
Placebo Placebo to AZD8871 and Anoro® Ellipta® orally 1 inhalation per day in treatment periods 1, 2 and 3 under all sequences A, B; C, D, E and F. 0 None 2 68 17 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vestibular neuronitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View