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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT01771250
Description: All randomized participants who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: None
Study: NCT01771250
Study Brief: A Study of Insulin Peglispro and Glargine on Fats 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
Insulin Peglispro Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. None None 0 14 4 14 View
Insulin Glargine Participants took a stable dose of Insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. None None 1 14 5 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dermoid cyst SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View