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 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
NCT ID:
NCT03430856
Description:
Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Frequency Threshold:
0
Time Frame:
From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks.
Study:
NCT03430856
Study Brief:
Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Insulin Tregopil (IN-105) - 45mg | At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. | 0 | None | 0 | 31 | 5 | 31 | View |
| Insulin Tregopil (IN-105) - 30mg | SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose. | 0 | None | 0 | 30 | 5 | 30 | View |
| Insulin Aspart | At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose | 0 | None | 0 | 30 | 4 | 30 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Vulval laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |