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 @ 6:39 PM
Ignite Modification Date: 2025-12-25 @ 4:09 PM
NCT ID: NCT05103657
Description: Treated Set (TS): consisted of all patients that were randomised and had received at least one administration of trial drug. Patients were analysed according to the actual received treatment.
Frequency Threshold: 5
Time Frame: "All-Cause Mortality" "Serious Adverse Events" and "Other Adverse Events": From first administration of BI 1358894 or placebo to last administration of BI 1358894 or placebo + 4 weeks of residual effect period, up to 13 weeks.
Study: NCT05103657
Study Brief: A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
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 Patients received orally, once daily for 8 consecutive weeks film-coated tablets of placebo matching BI 1358894. Placebo matching BI 1358894 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. 1 None 10 159 38 159 View
BI 1358894 125 mg Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. 0 None 12 157 56 157 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View