Adverse Events Module

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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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT05444556
Description: All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
Frequency Threshold: 5
Time Frame: Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
Study: NCT05444556
Study Brief: A Study of Imlunestrant (LY3484356) in Female Healthy 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
0.5 mg Repaglinide: Cohort 1 Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1. 0 None 0 27 2 27 View
800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1 Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3. 0 None 0 27 0 27 View
20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2 Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1. 0 None 0 27 3 27 View
800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2 Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3. 0 None 0 27 3 27 View
400 mg Imlunestrant (Day 1): Cohort 3 Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1. 0 None 0 32 9 32 View
200 mg Quinidine BID (Days 15 to 17): Cohort 3 Participants received twice-daily oral doses of 200 mg quinidine, administered alone from days 15 to 17. 0 None 0 32 3 32 View
400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3 Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18. 0 None 0 31 0 31 View
200 mg Quinidine BID (Days 19 to 24): Cohort 3 Participants received BID oral doses of 200 mg quinidine, administered alone from Days 19 to 24. 0 None 0 31 4 31 View
10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4 Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1. 0 None 0 27 0 27 View
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4 Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10. 0 None 0 26 1 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View