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 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
NCT ID:
NCT02714569
Description:
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Frequency Threshold:
5
Time Frame:
From Baseline to End of Study (Up to 10 Weeks)
Study:
NCT02714569
Study Brief:
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 5 mg LY | 5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B. | 0 | None | 0 | 8 | 5 | 8 | View |
| 100 mg LY | 100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B. | 0 | None | 0 | 12 | 1 | 12 | View |
| 600 mg of LY | 600 mg of LY was taken orally in one of four periods in Part A. | 0 | None | 0 | 5 | 0 | 5 | View |
| Placebo | Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B. | 0 | None | 0 | 25 | 2 | 25 | View |
| 1 mg LY3202328 (LY) | 1 mg of LY was taken orally in one of four periods in Part A. | 0 | None | 0 | 6 | 0 | 6 | View |
| 3 mg LY | 3 mg of LY was taken orally in one of four periods in Part A. | 0 | None | 0 | 6 | 0 | 6 | View |
| 10 mg LY | 10 mg of LY was taken orally in one of four periods in Part A. | 0 | None | 0 | 6 | 2 | 6 | View |
| 20 mg LY | 20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B. | 0 | None | 0 | 8 | 5 | 8 | View |
| 30 mg LY | 30 mg of LY was taken orally in one of four periods in Part A. | 0 | None | 0 | 6 | 1 | 6 | View |
| 30 mg LY Fed | 30 mg of LY (fed) was taken orally in one of four periods in Part A. | 0 | None | 0 | 4 | 0 | 4 | View |
| 300 mg LY | 300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B. | 0 | None | 2 | 14 | 6 | 14 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Alt increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Pr interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Pain in hip | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Stiff neck | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Dry cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dermatographic urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Papule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Flushed | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |