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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT01215435
Description: Safety analysis set includes all subjects who received at least one dose of the trial product.
Frequency Threshold: 5
Time Frame: The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Study: NCT01215435
Study Brief: Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-breakfast BIAsp 30 Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. None None 3 122 16 122 View
Pre-dinner BIAsp 30 Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels. None None 4 123 19 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View