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 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
NCT ID:
NCT01554618
Description:
The Safety Analysis Set consisted of all patients who received at least 1 dose of study medication. One patient who was randomized to placebo received a dose of exenatide in error and was subsequently reassigned to the exenatide treatment group for analyses based on actual treatment (ie, for analyses based on the Safety Analysis Set).
Frequency Threshold:
5
Time Frame:
After the first dose of study medication in period through the end of the treatment in period + 90 days for SAEs (or + 7 days for non-serious (i.e. Other) AEs. Overall time frame: up to maximum of approximately 37 weeks and 41 weeks for controlled assessment period and extension period, respectively.
Study:
NCT01554618
Study Brief:
Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Controlled Assessment Period - Exenatide | Patients received exenatide 2 mg SC injection once weekly for 24 weeks during the controlled assessment period. | 0 | None | 2 | 59 | 25 | 59 | View |
| Controlled Assessment Period - Placebo | Patients received placebo (matching with exenatide) SC injection once weekly for 24 weeks during the controlled assessment period. | 0 | None | 1 | 23 | 10 | 23 | View |
| Extension Period - Exenatide | Patients received open-label exenatide 2 mg SC injection once weekly for 28 weeks during the extension period. Patients in this treatment group had previously received exenatide during the controlled assessment period. | 0 | None | 3 | 50 | 10 | 50 | View |
| Extension Period - Placebo to Exenatide | Patients received open-label exenatide 2 mg SC injection once weekly for 28 weeks during the extension period. Patients in this treatment group had previously received placebo during the controlled assessment period. | 0 | None | 1 | 22 | 4 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |