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 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
NCT ID:
NCT03575403
Description:
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
Frequency Threshold:
0
Time Frame:
Four weeks
Study:
NCT03575403
Study Brief:
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
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 | Subjects received oral placebo capsules one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl. Placebos: Subjects will receive placebo capsules. Methylphenidate: Subjects will receive methylphenidate capsules. | 0 | None | 0 | 11 | 11 | 11 | View |
| Duloxetine (30 MG) | Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl. Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules. | 0 | None | 0 | 2 | 2 | 2 | View |
| Duloxetine (60 MG) | Subjects received 60 mg oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl. Duloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules. | 0 | None | 0 | 6 | 6 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Body Aches | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Ear Congestion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Change in Urination | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loss of Voice | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle Aches | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Changes in Sexual Function | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Sleepiness/Dowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sore Throat | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Stuffy/Runny nose | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unusual Bruising/Bleeding | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increased Appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Racing/Pounding Heart | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Itchness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Weight Change | SYSTEMATIC_ASSESSMENT | General disorders | None | View |