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 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
NCT ID:
NCT02004366
Description:
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency Threshold:
0
Time Frame:
13 weeks (average 5 days in hospital and 12 weeks after discharge)
Study:
NCT02004366
Study Brief:
Linagliptin Inpatient Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Linagliptin In-hospital | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | 0 | None | 1 | 128 | 25 | 128 | View |
| Basal Bolus In-hospital | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 0 | None | 0 | 122 | 15 | 122 | View |
| Linagliptin on Discharge | Patients with admission A1C \< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily. Linagliptin: Patients with admission A1C \< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 0 | None | 12 | 92 | 3 | 92 | View |
| Linagliptin+50%Glargine Dose on d/c | Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. Linagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months. | 0 | None | 14 | 93 | 1 | 93 | View |
| Linagliptin+80%Glargine Dose on d/c | Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. Linagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months. | 0 | None | 9 | 39 | 0 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ICU admission | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pulmonary | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Resurgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Metabolic | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hematologic | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pulmonary | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Surgical Reintervention | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |