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 @ 3:24 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT01301092
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01301092
Study Brief: A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.
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: 0.1 mg IV LY2189265 Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265 None None 0 6 0 6 View
Part B: 0.1 mg IV LY2189265 Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2. None None 0 16 7 16 View
Part B: 1.5 mg SC LY2189265 Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. None None 0 16 9 16 View
Part C: 0.75 mg IM LY2189265 Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2. None None 0 8 3 8 View
Part C: 0.75 mg SC LY2189265 Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. None None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View