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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT01278160
Description: The safety analysis set contained all subjects exposed to at least one dose of investigational products.
Frequency Threshold: 5
Time Frame: The adverse events were collected in a timespan of 17 weeks.
Study: NCT01278160
Study Brief: Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIAsp 30 (2:1) After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals None None 1 89 0 89 View
BIAsp 30 (1:1) After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals None None 2 90 0 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Other Events(If Any):