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 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
NCT ID:
NCT02773368
Description:
Results are based on the safety analysis set, which included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
Frequency Threshold:
5
Time Frame:
Adverse events (AEs) were collected from first day (week 0) of exposure to randomised treatment of 26 weeks + 30 days follow-up visits after the last dose on trial product. All reported AEs are treatment emergent (i.e., TEAE).
Study:
NCT02773368
Study Brief:
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| IDegLira | Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. | 0 | None | 6 | 209 | 49 | 209 | View |
| IGlar | Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. | 0 | None | 7 | 210 | 45 | 210 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
| Cardiovascular evaluation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20 | View |
| Device failure | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 20 | View |
| Gastrointestinal stromal tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | View |
| Infected skin ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20 | View |