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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT04011735
Description: Full Analysis Set (FAS): All enrolled patients who met all the eligibility criteria of the study and who had received at least one dose of ther re-usable Respimat SMI product during the study period.
Frequency Threshold: 5
Time Frame: From study entry until end of study, up to 6 weeks.
Study: NCT04011735
Study Brief: Re-usable Respimat® Soft MistTM Inhaler 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
Respimat® SMI-experienced: Maintenance With Re-usable SMI Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period). 0 None 0 133 0 133 View
Respimat® SMI-experienced: Switching to Re-usable SMI Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period). 0 None 0 70 0 70 View
Respimat® SMI-naïve Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period). 0 None 0 56 0 56 View
Serious Events(If Any):
Other Events(If Any):