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 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
NCT ID:
NCT00575159
Description:
Safety population was used.
Frequency Threshold:
0
Time Frame:
Approximately up to 6 months
Study:
NCT00575159
Study Brief:
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water. | 0 | None | 0 | 10 | 3 | 10 | View |
| Placebo+ Prandial Insulin | Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water. | 0 | None | 0 | 10 | 4 | 10 | View |
| GSK189075 50mg | Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water. | 0 | None | 0 | 10 | 5 | 10 | View |
| GSK189075 150mg | Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water. | 0 | None | 0 | 10 | 6 | 10 | View |
| GSK189075 500mg | Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water. | 0 | None | 0 | 10 | 4 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |