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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT04390568
Description: Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Frequency Threshold: 5
Time Frame: Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days.
Study: NCT04390568
Study Brief: A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Spesolimap - 900 mg - IV A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast. 0 None 1 10 9 10 View
Spesolimap - 1200 mg - IV A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast. 0 None 0 10 8 10 View
Spesolimap - 600 mg - SC A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast. 0 None 0 10 9 10 View
Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast. 0 None 0 10 8 10 View
Spesolimap - 300 mg - Subcutaneous (SC) A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast. 0 None 0 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gingival swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Acne pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Eosinophil percentage increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Red blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Reticulocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Reticulocyte percentage increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Urobilinogen urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinalgia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Acne cystic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View