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 @ 12:54 PM
Ignite Modification Date: 2025-12-25 @ 12:17 PM
NCT ID: NCT00842361
Description: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Frequency Threshold: 5
Time Frame: The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
Study: NCT00842361
Study Brief: Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SIAC Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted None None 1 33 5 33 View
Mix30 Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted. None None 0 32 3 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Supraventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View