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 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 4:09 PM
NCT ID:
NCT00696657
Description:
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
Frequency Threshold:
5
Time Frame:
The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
Study:
NCT00696657
Study Brief:
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
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 | Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 1 | 46 | 9 | 46 | View |
| Semaglutide 0.1 mg | Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 1 | 47 | 23 | 47 | View |
| Semaglutide 0.2 mg | Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 1 | 43 | 14 | 43 | View |
| Semaglutide 0.4 mg | Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 2 | 48 | 27 | 48 | View |
| Semaglutide 0.8 mg | Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 0 | 42 | 32 | 42 | View |
| Semaglutide 0.8 mg (With Titration) | Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11-week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 1 | 43 | 29 | 43 | View |
| Semaglutide 1.6 mg (With Titration) | Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 2 | 47 | 39 | 47 | View |
| Liraglutide 1.2 mg | Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 0 | 45 | 18 | 45 | View |
| Liraglutide 1.8 mg | Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 0 | None | 0 | 50 | 21 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18 | View |
| Arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18 | View |