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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:54 PM
NCT ID: NCT03123094
Description: Treated set (TS): TS includes all subjects dispensed trial medication and documented to have taken at least one dose of investigational treatment.
Frequency Threshold: 5
Time Frame: From first drug administration until the end of trial examination, up to 151 days.
Study: NCT03123094
Study Brief: Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching to Spesolimab Subjects administered placebo matching to spesolimab solution for infusion as intravenous as 90 min infusion or subcutaneous injection on day 1 of visit 2. 0 None 0 8 2 8 View
Spesolimab Low Dose Group (Intravenous) Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2. 0 None 0 6 1 6 View
Spesolimab Medium Dose Group (Intravenous) Subjects were administered intravenously a single dose of solution for infusion of spesolimab in the range of 300 -1200 milligrams (mg) as 90 minutes infusion on day 1 of visit 2. 0 None 0 6 1 6 View
Spesolimab High Dose Group Subjects administered single dose of 1200 mg BI 655130 solution for infusion as intravenous as 90 min infusion on day 1 visit 2. 0 None 0 6 1 6 View
Spesolimab Low Dose Group (Subcutaneous) Subjects were administered a single dose of solution for injection of spesolimab in the range of 300-1200 milligrams (mg) as subcutaneous injection on day 1 of visit 2. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View