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 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT00542620
Description: All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
Frequency Threshold: 5
Time Frame: Adverse events are collected during treatment period (8 weeks)
Study: NCT00542620
Study Brief: Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mixed Injection Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed None None 0 12 5 12 View
Separate Injection Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed None None 0 13 9 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Orthodontic procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View