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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01486966
Description: Safety analysis set included all subjects receiving at least one dose of the trial products. All adverse events summarised were treatment emergent adverse events.
Frequency Threshold: 5
Time Frame: The adverse events were collected in a timeframe of 2 weeks.
Study: NCT01486966
Study Brief: Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 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 Detemir + Insulin Aspart ± Metformin Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial. None None 0 29 0 29 View
Insulin NPH + Human Soluble Insulin ± Metformin Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial. None None 0 29 2 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper restiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View