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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks ITI-007 (Lumateperone) | 0 | None | 5 | 180 | 72 | 180 | View |
| Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks Lumateperone (ITI-007) | 0 | None | 0 | 184 | 67 | 184 | View |
| Part A Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo | 1 | None | 1 | 185 | 31 | 185 | View |
| Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for up to 6 months Lumateperone (ITI-007) | 0 | None | 4 | 127 | 55 | 127 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Anemia postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Panic Attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Agression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Procedural hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |