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: 2025-12-25 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:23 AM
NCT ID: NCT01846702
Description: All randomized participants who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: None
Study: NCT01846702
Study Brief: A Study of LY3084077 in 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
LY3084077 Cohort 6 100 mg single dose of LY3084077 administered SC None None 0 6 6 6 View
Placebo Cohort 1 Single dose of placebo matching LY3084077 administered SC. None None 1 6 6 6 View
LY3084077 Cohort 2 1 mg single dose of LY3084077 administered SC. None None 0 6 6 6 View
LY3084077 Cohort 3 3 mg single dose of LY3084077 administered SC None None 0 6 3 6 View
LY3084077 Cohort 4 10 mg single dose of LY3084077 administered SC None None 0 6 3 6 View
LY3084077 Cohort 5 30 mg single dose of LY3084077 administered SC None None 0 6 5 6 View
LY3084077 Cohort 7 150 mg single dose of LY3084077 administered SC None None 0 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Increased upper airway secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Eyelid pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View