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 |
|---|---|---|---|---|---|---|---|---|
| Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | None | 0 | 13 | 0 | 13 | View |
| Lean Diabetes Subjects | N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | None | 0 | 20 | 0 | 20 | View |
| Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | None | 0 | 15 | 0 | 15 | View |
| Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | None | 0 | 16 | 0 | 16 | View |
| Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | None | 0 | 9 | 0 | 9 | View |