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 @ 12:50 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT03083561
Description: All enrolled participants.
Frequency Threshold: 5
Time Frame: Up To 31 Days
Study: NCT03083561
Study Brief: A Study of LY3337641 in Japanese and Caucasian 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
80 mg LY3337641 SD Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period. 0 None 0 6 1 6 View
160 mg LY3337641 SD Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period. 0 None 0 6 2 6 View
Placebo MD Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period. 0 None 0 3 3 3 View
30 mg LY3337641 MD Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period. 0 None 0 9 6 9 View
Placebo SD Participants received single oral dose of placebo tablet with a two week follow-up period. 0 None 0 6 1 6 View
5 mg LY3337641 SD Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Medical device site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View