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 @ 12:48 PM
Ignite Modification Date:
2025-12-25 @ 12:15 PM
NCT ID:
NCT04659161
Description:
The Safety population included all participants who received at least one dose of study medication.
Frequency Threshold:
2
Time Frame:
From the start of study drug administration up to Week 5.
Study:
NCT04659161
Study Brief:
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| KarXT | Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period. | 0 | None | 2 | 126 | 95 | 126 | View |
| Placebo | Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks. | 0 | None | 2 | 125 | 73 | 125 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.1 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Schizophrenia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.1 | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.1 | View |