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 @ 4:17 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
NCT ID:
NCT04512066
Description:
None
Frequency Threshold:
5
Time Frame:
4 weeks for double-blind treatment period Up to 48 weeks for extension period
Study:
NCT04512066
Study Brief:
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension. Note: This arm was only in the double-blind treatment period. | 0 | None | 1 | 72 | 23 | 72 | View |
| RO6889450 45 mg (Double-blind Treatment Period) | Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks. | 0 | None | 2 | 65 | 14 | 65 | View |
| RO6889450 150 mg (Double-blind Treatment Period) | Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks. | 0 | None | 1 | 68 | 23 | 68 | View |
| Risperidone 4 mg (Double-blind Treatment Period) | Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks. | 0 | None | 0 | 71 | 36 | 71 | View |
| Placebo - RO6889450 45 mg | Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension. Note: This arm started in the extension period. | 0 | None | 3 | 25 | 5 | 25 | View |
| Placebo - RO6889450 150 mg | Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension. Note: This arm started in the extension period. | 1 | None | 3 | 25 | 6 | 25 | View |
| RO6889450 45 mg (Extension Period) | Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks. | 0 | None | 1 | 41 | 7 | 41 | View |
| RO6889450 150 mg (Extension Period) | Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks. | 0 | None | 6 | 45 | 12 | 45 | View |
| Risperidone 4 mg (Extension Period) | Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks. | 0 | None | 1 | 53 | 5 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Schizophrenia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Gun shot wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Schizophrenia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |