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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pramlintide (Symlin) | Participants in this study were asked to complete 4 study visits. Study visit 1 was a screening visit. Eligible individuals who provided informed consent were asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom log was reviewed. Pramlintide was prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times. Study visit 3 occured at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat mixed meal tolerance test. Pramlintide: See description above (arm description). | 0 | None | 1 | 22 | 9 | 22 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Cholecystitis (prior to treatment with study drug) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Elevated liver enzymes | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Altered taste (during treatment with study drug) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ethanol abuse / intoxication | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Trembling | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea (with urgency and incontinence) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Auditory hallucinations | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cold feeling behind eyes. | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nightmares | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increase in baseline anxiety. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sinus infection (Visit 4, following treatment with study drug) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Weight loss (during study drug treatment) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |