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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT01769404
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01769404
Study Brief: A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1: 0.2-0.6 U/kg LY2605541 Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. None None 0 9 1 9 View
Cohort 1: 0.2-0.6 U/kg Insulin Glargine Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. None None 0 7 3 7 View
Cohort 2: 0.2-0.6 U/kg LY2605541 Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. None None 0 13 1 13 View
Cohort 2: 0.2-0.6 U/kg Insulin Glargine Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. None None 0 13 3 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View