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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT04846868
Description: Treated Set (TS): all patients who signed informed consent and were treated with at least one dose of the trial medication.
Frequency Threshold: 5
Time Frame: All-cause mortality: From randomization until individual end of study. Up to 246 days. Adverse event reporting: From first drug administration to last drug administration, plus residual effect period OR from first drug administration until first drug administration on the extension trial 1346-0014. Up to 230 days.
Study: NCT04846868
Study Brief: Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Iclepertin 10 mg Patients with schizophrenia took orally once a day one 10 milligram (mg) tablet of iclepertin. 1 None 12 312 81 312 View
Placebo-matching Iclepertin 10 mg Patients with schizophrenia took orally once a day one tablet of placebo-matching iclepertin. 1 None 16 307 91 307 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Central serous chorioretinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View