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 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
NCT ID:
NCT05656534
Description:
None
Frequency Threshold:
1
Time Frame:
2 months.
Study:
NCT05656534
Study Brief:
Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use 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+fMRI+EMG | Individuals will take a placebo pill during the Acute Drug Challenge and daily for 28 days. Placebo: This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment lab visits (EMG, fMRI). The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visits, participants will take one pill at the Acute Drug Challenge under medical supervision. Ninety minutes post ingestion participants will complete the EMG paradigm. At the end of the visit participants will be provided a blister pack with 28 pills. Participants will be instructed to take one pill orally about 30 minutes prior to sleep time each night for 28 days. Participants will be provided education about common side effects. Participants will complete daily surveys to monitor side. At the end of the 28 days, participants will complete post-treatment lab visits. | 0 | None | 0 | 15 | 3 | 15 | View |
| Suvorexant+fMR+EMG | Individuals will take 10mg of suvorexant (Merck \& Co Inc.) during the Acute Drug Challenge and daily for 28 days. Suvorexant: This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment lab visits (EMG, fMRI). Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. After the pre-treatment visits participants will take one pill of SUV at the Acute Drug Challenge under medical supervision. Ninety minutes post ingestion participants will complete an EMG. Laboratory assessments will occur during peak concentration, 2 hours post-ingestion. At the end of the visit, participants will be given a blister pack with 28 pills. Participants will be instructed to take one pill orally about 30 minutes prior to sleep time each night for 28 days. Participants will be provided education about common side effects. Participants will complete daily surveys to monitor side effects and potential drug-drug interactions. At the end of the 28 days, participants will complete post-treatment lab visits. | 0 | None | 0 | 13 | 4 | 13 | View |
| Placebo + EMG Only | Individuals will take a placebo pill during the Acute Drug Challenge and daily for 28 days. Placebo: This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment lab visits (EMG only). The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visits, participants will take one pill at the Acute Drug Challenge under medical supervision. Ninety minutes post ingestion participants will complete the EMG paradigm. At the end of the visit participants will be provided a blister pack with 28 pills. Participants will be instructed to take one pill orally about 30 minutes prior to sleep time each night for 28 days. Participants will be provided education about common side effects. Participants will complete daily surveys to monitor side. At the end of the 28 days, participants will complete post-treatment lab visits. | 0 | None | 0 | 18 | 3 | 18 | View |
| Suvorexant + EMG Only | Individuals will take 10mg of suvorexant (Merck \& Co Inc.) during the Acute Drug Challenge and daily for 28 days. Suvorexant: This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment lab visits (EMG only). Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. After the pre-treatment visits participants will take one pill of SUV at the Acute Drug Challenge under medical supervision. Ninety minutes post ingestion participants will complete an EMG. Laboratory assessments will occur during peak concentration, 2 hours post-ingestion. At the end of the visit, participants will be given a blister pack with 28 pills. Participants will be instructed to take one pill orally about 30 minutes prior to sleep time each night for 28 days. Participants will be provided education about common side effects. Participants will complete daily surveys to monitor side effects and potential drug-drug interactions. At the end of the 28 days, participants will complete post-treatment lab visits. | 0 | None | 0 | 18 | 3 | 18 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Sleep Disturbances | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |