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 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
NCT ID:
NCT02963766
Description:
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Frequency Threshold:
5
Time Frame:
Up To 56 Weeks
Study:
NCT02963766
Study Brief:
A Study of Dulaglutide (LY2189265) in Children and 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE) | Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | None | 0 | 47 | 18 | 47 | View |
| 0.75 mg Dulaglutide: OLE | Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | None | 1 | 49 | 16 | 49 | View |
| 1.5 mg Dulaglutide: OLE | Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | None | 2 | 50 | 20 | 50 | View |
| Placebo: Double-Blind Period | Participants received placebo administered SC for 26 weeks. | 0 | None | 3 | 51 | 26 | 51 | View |
| 0.75 mg Dulaglutide: Double-Blind Period | Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks. | 0 | None | 1 | 51 | 25 | 51 | View |
| 1.5 mg Dulaglutide: Double-Blind Period | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks. | 0 | None | 1 | 52 | 28 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stress fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.1 | View |
| Nonalcoholic fatty liver disease | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 24.1 | View |
| Genital herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Pilonidal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Carbon monoxide poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.1 | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |