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 @ 4:07 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
NCT ID:
NCT01588366
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01588366
Study Brief:
The Effects of LY2409021 on the Liver
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 - Healthy (Part A) | Placebo administered orally, QD for 28 days to healthy participants. | None | None | 0 | 2 | 1 | 2 | View |
| 60 mg LY2409021 - Healthy (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to healthy participants. | None | None | 0 | 7 | 7 | 7 | View |
| Placebo - T2DM (Parts A and B) | Placebo administered orally, QD for 28 days to participants with T2DM. | None | None | 0 | 5 | 4 | 5 | View |
| 15 mg LY2409021 - T2DM (Part B) | 15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. | None | None | 2 | 9 | 7 | 9 | View |
| 60 mg LY2409021 - T2DM (Part A) | 60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM. | None | None | 0 | 7 | 4 | 7 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Catheter site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Catheter site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Catheter site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Vessel puncture site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |