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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT01701258
Description:
None
Frequency Threshold:
0
Time Frame:
3 years, 10 months
Study:
NCT01701258
Study Brief:
An Investigation of Early Life Stress and Depression
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| All Baseline Participants | Participants that were eligible for the study after the screening visit (session 1). These participants were invited to participate in the other study sessions. | 0 | None | 0 | 96 | 0 | 96 | View |
| All Participants | All participants that went through the assessment (session 1) regardless if they were eligible or ineligible. | 0 | None | 0 | 153 | 0 | 153 | View |
| Control Group | Control subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions. | 0 | None | 0 | 26 | 0 | 26 | View |
| Control-amisulpride (fMRI Session) | After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session. | 0 | None | 0 | 11 | 0 | 11 | View |
| Control-placebo (fMRI Session) | After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session. | 0 | None | 0 | 11 | 0 | 11 | View |
| MDD Group | Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions. | 0 | None | 0 | 17 | 0 | 17 | View |
| MDD-amisulpride (fMRI Session) | After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session. | 0 | None | 0 | 9 | 0 | 9 | View |
| MDD-placebo (fMRI Session) | After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session. | 0 | None | 0 | 8 | 0 | 8 | View |
| CSA/RES | Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions. | 0 | None | 0 | 24 | 0 | 24 | View |
| CSA/RES-amisulpride (fMRI Session) | After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session. | 0 | None | 0 | 6 | 0 | 6 | View |
| CSA/RES-placebo (fMRI Session) | After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session. | 0 | None | 0 | 6 | 0 | 6 | View |
| CSA/MDD Group | Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions. | 0 | None | 0 | 29 | 0 | 29 | View |
| CSA/MDD-amisulpride (fMRI Session) | After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session. | 0 | None | 0 | 10 | 0 | 10 | View |
| CSA/MDD-placebo (fMRI Session) | After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session. | 0 | None | 0 | 7 | 0 | 7 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other Adverse Events | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |