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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT02188303
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02188303
Study Brief: A Study of LY2944876 in Healthy Japanese and Non-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
Cohorts 1-3 - Placebo Placebo, Single Dose Administered Subcutaneously (SC) None None 0 6 0 6 View
Cohort 1 - LY2944876 10 mg LY2944876 10 mg, Single Dose Administered SC None None 0 6 4 6 View
Cohort 2 - LY2944876 30 mg LY2944876 30 mg, Single Dose Administered SC None None 0 6 4 6 View
Cohort 3 - LY2944876 50 mg LY2944876 50 mg, Single Dose Administered SC None None 0 6 6 6 View
Cohort 4 - Placebo Placebo Administered QD SC, Days 1-7 None None 0 4 4 4 View
Cohort 4 - LY2944876 40 mg LY2944876 40 mg Administered QD SC, Days 1-7 None None 0 12 12 12 View
Cohort 5 - Placebo Placebo Administered QD SC, Day 1, Day 4, and Day 6. None None 0 2 2 2 View
Cohort 5 - 15-80 mg Titrated LY2944876 LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6. None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Joint lock SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Rectal tenesmus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View