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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
NCT ID:
NCT00615433
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00615433
Study Brief:
Lurasidone HCl A Phase 3 Study of Patients With Acute 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 |
|---|---|---|---|---|---|---|---|---|
| 40mg | Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication. | None | None | 2 | 119 | 90 | 119 | View |
| 120mg | 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication. | None | None | 6 | 118 | 96 | 118 | View |
| 15mg Olz | 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication. | None | None | 5 | 122 | 98 | 122 | View |
| Placebo | Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated). | None | None | 5 | 116 | 84 | 116 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | None | Cardiac disorders | None | View |
| Angina Pectoris | None | Cardiac disorders | None | View |
| Sinus Tachycardia | None | Cardiac disorders | None | View |
| Heamatemesis | None | Gastrointestinal disorders | None | View |
| Hepatitis | None | Hepatobiliary disorders | None | View |
| Bronchopneumonia | None | Infections and infestations | None | View |
| Agitation | None | Psychiatric disorders | None | View |
| Panic Attack | None | Psychiatric disorders | None | View |
| Psychotic Disorder | None | Psychiatric disorders | None | View |
| Schizophrenia | None | Psychiatric disorders | None | View |
| Substance Abuse | None | Psychiatric disorders | None | View |
| Suicidal Ideation | None | Psychiatric disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | None | View |
| Dry Mouth | None | Gastrointestinal disorders | None | View |
| Dyspepsia | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Salivary Hypersecretion | None | Gastrointestinal disorders | None | View |
| Tootache | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Weight Increased | None | Investigations | None | View |
| Decreased Appetite | None | Metabolism and nutrition disorders | None | View |
| Increased Appetite | None | Metabolism and nutrition disorders | None | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal Stiffness | None | Musculoskeletal and connective tissue disorders | None | View |
| Akathisia | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Dystonia | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Parkinsonism | None | Nervous system disorders | None | View |
| Sedation | None | Nervous system disorders | None | View |
| Somnolence | None | Nervous system disorders | None | View |
| Tremor | None | Nervous system disorders | None | View |
| Agitation | None | Psychiatric disorders | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Psychotic Disorder | None | Psychiatric disorders | None | View |
| Restlessness | None | Psychiatric disorders | None | View |