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 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
NCT ID:
NCT05227703
Description:
None
Frequency Threshold:
2
Time Frame:
All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 80 days for the Placebo group, 67.5 days for the Emraclidine 15 mg group, and 64.0 days for the Emraclidine 30 mg group.
Study:
NCT05227703
Study Brief:
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Emraclidine 15mg QD | Participants received a single daily oral dose of Emraclidine 15 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose. | 0 | None | 3 | 130 | 47 | 130 | View |
| Emraclidine 30mg QD | Participants received a single daily oral dose of Emraclidine 30 mg each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose. | 0 | None | 1 | 131 | 50 | 131 | View |
| Placebo | Participants received a single daily oral dose of Placebo each morning from Day 1 (baseline) through Day 45. Participants (completers and early withdrawals) were followed for safety up to approximately 28 days after the last dose. | 0 | None | 1 | 130 | 47 | 130 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| NEUROLEPTIC MALIGNANT SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| ACUTE PSYCHOSIS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| SCHIZOPHRENIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.0) | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| TINEA PEDIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| TOOTH ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |