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 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:46 PM
NCT ID: NCT02293551
Description: 54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT02293551
Study Brief: A Study of Lispro Formulations 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
Part A: Lispro (7.28 U - Test B) Formulation B: Single dose of lispro administered SC in one of five periods. None None 0 24 4 24 View
Part A: Lispro (7.28 U - Test C) Formulation C: Single dose of lispro administered SC in one of five periods. None None 0 24 4 24 View
Part A: Lispro (7.28 U - Test D) Formulation D: Single dose of lispro administered SC in one of five periods. None None 0 24 2 24 View
Part B: Lispro (7.28 U - Test B) Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. None None 0 28 6 28 View
Part B: Lispro (15.47 U - Test B) Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. None None 0 28 3 28 View
Part B: Lispro (30.03 U - Test B) Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. None None 0 29 7 29 View
Part A: Lispro (7.0 U - Reference) Reference formulation: Single dose of lispro administered SC in one of five periods. None None 0 24 4 24 View
Part A: Lispro (7.28 U - Test A) Formulation A: Single dose of lispro administered SC in one of five periods. None None 0 24 4 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View