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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT01570751
Description: The SAS 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 32 weeks + 7 days follow up
Study: NCT01570751
Study Brief: A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IDeg Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B. None None 4 140 2 140 View
IGlar Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B. None None 4 142 9 142 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Epididymitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View