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 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
NCT ID:
NCT02582905
Description:
Specific adverse events (AEs) and symptoms reported by more than one participant are grouped by the specific AE or symptom. Symptoms that were reported only once are grouped by system (e.g., respiratory, GI, etc.). AEs of participants who presented the same symptom during their follow-up visit were included only once in reporting.
Frequency Threshold:
0
Time Frame:
12 weeks.
Study:
NCT02582905
Study Brief:
Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pregnenolone | Pregnenolone will be given beginning at 50 mg BID with an increase to 100 mg BID at week 1, 150 mg BID at week 2, and 250 mg BID at weeks 3-12. Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and also in the brain. Pregnenolone produces other neuroactive steroids. | 0 | None | 4 | 37 | 7 | 37 | View |
| Placebo | Matching placebo given beginning at 1 capsule twice daily (BID) increasing to 2 capsules BID at week 1, 3 capsules BID at week 2, and 4 capsules BID at weeks 3-12. Placebo: Inactive ingredient matching the active comparators in appearance. | 0 | None | 3 | 29 | 11 | 29 | View |
| Citicoline | Citicoline will be given beginning at 250 mg BID with an increase to 500 mg BID at week 1, 750 mg BID at week 2, and 1000 mg BID at weeks 3-12. Citicoline: Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body. | 0 | None | 2 | 30 | 9 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Panic Attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Suicide attempts | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Inpatient alcohol treatment | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Overdose by partner on study medication | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea or vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Upper Respiratory Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Blurry vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Weight gain or increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Sedation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increased urinary frequency or difficulty | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Fractured bone | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Numbness or tingling | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Restlessness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Decreased libido | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cognitive difficulty | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Panic and anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Indigestion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Increased perspiration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Dental abscess | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increased thirst | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Increased alcohol use | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Possible liver disease | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vivid dreams | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Asthma attack | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sore throat | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Metallic taste | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sprained ankle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Motor vehicle accident | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Leg pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |