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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT03151395
Description: In the Participant flow section, there are 2 participants reported with "adverse event" reason for not completed: 1 was for SAE described in the Serious Adverse Events section below, and the other one was for a SAE not related to study procedure, and hence, no information (System Organ Class \& Preferred Term) was collected, as per protocol, for this SAE. Hospitalizations that were associated with the disease being studied were not collected as AEs or as SAEs as per protocol.
Frequency Threshold: 0
Time Frame: Unsolicited adverse events and serious adverse events (SAE) related to study procedures have been collected during the whole study period (from Month 0 to Month 12.
Study: NCT03151395
Study Brief: Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Group Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits. 2 None 1 197 1 197 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia necrotizing SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.1 View