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 @ 1:38 AM
Ignite Modification Date: 2025-12-25 @ 11:53 PM
NCT ID: NCT00623194
Description: The safety analysis set is all subjects exposed to at least one dose of trial drug.
Frequency Threshold: 5
Time Frame: The adverse events were collected over a period of 104 weeks.
Study: NCT00623194
Study Brief: Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
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 detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) None None 12 146 108 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis shigella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 11.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 11.1 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 11.1 View
Hypoglycaemia unconsciousness SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 11.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Burns second degrees SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Acute Tonsilliitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 11.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View