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 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
NCT ID:
NCT04586920
Description:
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Frequency Threshold:
5
Time Frame:
Baseline to Up To Day 26
Study:
NCT04586920
Study Brief:
A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A - Placebo (Fasted) | Participants received single oral dose of placebo under fasting condition. | 0 | None | 0 | 10 | 0 | 10 | View |
| Part A - Placebo (Fed) | Participants received single oral dose of placebo under fed condition. | 0 | None | 0 | 2 | 1 | 2 | View |
| Part A - 10 Milligram (mg) LY3509754 (Fasted) | Participants received a single oral dose of 10 mg LY3509754 under fasting condition. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part A - 30 mg LY3509754 (Fasted) | Participants received a single oral dose of 30 mg LY3509754 under fasting condition. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part A - 100 mg LY3509754 (Fasted) | Participants received a single oral dose of 100 mg LY3509754 under fasting condition. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part A - 300 mg LY3509754 (Fasted) | Participants received a single oral dose of 300 mg LY3509754 under fasting condition. | 0 | None | 0 | 9 | 0 | 9 | View |
| Part A - 300 mg LY3509754 (Fed) | Participants received a single oral dose of 300 mg LY3509754 under fed condition. | 0 | None | 0 | 9 | 2 | 9 | View |
| Part A - 1000 mg LY3509754 (Fasted) | Participants received a single oral dose of 1000 mg LY3509754 under fasting condition. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part A - 2000 mg LY3509754 (Fasted) | Participants received a single oral dose of 2000 mg LY3509754 under fasting condition. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part B - Placebo Alone (Day 1) | Participants received a single oral dose of placebo on Day 1. | 0 | None | 0 | 3 | 0 | 3 | View |
| Part B - Placebo + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10. | 0 | None | 0 | 3 | 0 | 3 | View |
| Part B - 200 mg Itraconazole (Days 4 to 13) | Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13. | 0 | None | 0 | 11 | 4 | 11 | View |
| Part B - 10 mg LY3509754 Alone (Day 1) | Participants received a single oral dose of 10 mg LY3509754 on Day 1. | 0 | None | 0 | 8 | 0 | 8 | View |
| Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10. | 0 | None | 0 | 8 | 1 | 8 | View |
| Part C - Placebo QD [Cohorts 1 and 3] | Participants received oral doses of placebo QD for 14 Days. | 0 | None | 0 | 4 | 1 | 4 | View |
| Part C - 100 mg LY3509754 QD [Cohort 1] | Participants received oral doses of 100 mg LY3509754 QD for 14 Days. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part C - 1.2 mg Midazolam (Day -2) [Cohort 2] | Participants received 1.2 mg midazolam as an oral solution on Day -2. | 0 | None | 0 | 10 | 1 | 10 | View |
| Part C - Placebo QD (Days 1 to 14) [Cohort 2] | Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. | 0 | None | 0 | 2 | 0 | 2 | View |
| Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2] | Participants received oral doses of 300 mg LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. | 0 | None | 0 | 8 | 2 | 8 | View |
| Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15. | 0 | None | 0 | 2 | 1 | 2 | View |
| Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15. | 0 | None | 0 | 8 | 0 | 8 | View |
| Part C - 1000 mg LY3509754 QD [Cohort 3] | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part D (Japanese) - Placebo QD | Participants received oral doses of placebo QD for 15 Days. | 0 | None | 0 | 4 | 2 | 4 | View |
| Part D (Japanese) - 400 mg LY3509754 QD | Participants received oral doses of 400 mg LY3509754 QD for 15 Days. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part D (Japanese) - 1000 mg LY3509754 QD | Participants received oral doses of 1000 mg LY3509754 QD for 15 Days. | 0 | None | 0 | 6 | 4 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Medical device site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Sensation of foreign body | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Vessel puncture site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Gallbladder polyp | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Hepatitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Asymptomatic COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Asymptomatic bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Gingival injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Influenza b virus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Saliva altered | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Hepatitis e | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Mouth injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Vitreous detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |