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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT06139302
Description: Adverse events were reported for the treated set (TS). The treated set included all subjects who were treated with at least one dose of nerandomilast. The treatment assignments were determined based on the first treatment the subjects received. The treated set was used for safety analyses.
Frequency Threshold: 5
Time Frame: Serious adverse events, other adverse events and all-cause mortality: From time of trial drug administration up to 7 days.
Study: NCT06139302
Study Brief: A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nerandomilast 9 mg Participants were administered a single film-coated tablet of 9 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs). 0 None 0 6 1 6 View
Nerandomilast 18 mg Participants were administered a single film-coated tablet of 18 mg of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (hrs). 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View