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 @ 1:47 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT02311894
Description: The safety population included all participants who received at least 1 dose of the investigational product.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were reported from Day 1 until 28 days after last dose of study medication for up to 12 months.
Study: NCT02311894
Study Brief: A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Somatropin Children will receive daily subcutaneous (SC) injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year. 0 None 0 82 40 82 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 20.1 View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders 20.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders 20.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 20.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 20.1 View