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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
NCT ID:
NCT01733758
Description:
The nonserious AEs and SAEs are reported for the Safety Population, comprised of all participants who received \>= 1 dose of study treatment. Randomized treatment allocation was by design imbalanced in a ratio of 3:6:6:4 for placebo, albiglutide 30 mg, albiglutide 50 mg, and liraglutide. Non-serious AEs excludes hypoglycemia events.
Frequency Threshold:
5
Time Frame:
On-therapy non-serious AEs and serious AEs (SAEs), events with an onset on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.
Study:
NCT01733758
Study Brief:
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
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 - Before Switch | (Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. | None | None | 0 | 77 | 33 | 77 | View |
| Placebo - After Switch | (After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52. | None | None | 0 | 65 | 24 | 65 | View |
| Albiglutide 30 mg Weekly | Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52. | None | None | 5 | 160 | 85 | 160 | View |
| Albiglutide 50 mg Weekly | Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52. | None | None | 6 | 150 | 76 | 150 | View |
| Open Label Liraglutide 0.9 mg Daily | Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52. | None | None | 0 | 103 | 46 | 103 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Gastric cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Pancreatic carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Plasma cell myeloma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Rectal Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Rathke's cleft cyst | None | Congenital, familial and genetic disorders | MedDRA | View |
| Macular oedema | None | Eye disorders | MedDRA | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA | View |
| Pulmonary tuberculosis | None | Infections and infestations | MedDRA | View |
| Spinal compression fracture | None | Injury, poisoning and procedural complications | MedDRA | View |
| Cerebellar haemorrhage | None | Nervous system disorders | MedDRA | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA | View |
| Nausea | None | Gastrointestinal disorders | MedDRA | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bronchitis | None | Infections and infestations | MedDRA | View |
| Pharyngitis | None | Infections and infestations | MedDRA | View |
| Injection site erythema | None | General disorders | MedDRA | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA | View |
| Upper respiratory tract inflammation | None | Respiratory, thoracic and mediastinal disorders | MedDRA | View |