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 |
|---|---|---|---|---|---|---|---|---|
| Dapagliflozin: ad Libitum Dietary Intake | Daily oral administration of dapagliflozin with ad libitum dietary intake. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study. Dapagliflozin Ad libitum dietary intake | 0 | None | 0 | 3 | 3 | 3 | View |
| Dapagliflozin: Weight Maintenance | Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. The dose of dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study. Dapagliflozin Weight maintenance | 0 | None | 0 | 1 | 1 | 1 | View |
| Placebo: ad Libitum Dietary Intake | Daily oral administration of a placebo with ad-libitum dietary intake. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study. Placebo Ad libitum dietary intake | 0 | None | 0 | 3 | 1 | 3 | View |
| Placebo: Dietary Restriction | Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. Matching placebo for dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study. Placebo Dietary restriction | 0 | None | 0 | 2 | 1 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stomach Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loose Stool | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| increase in urination | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever and sore throat | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Stuffy Nose | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |