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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT01028560
Description: Definition: Serious adverse events= hospitalization, death In the immunotherapy group, all allergic or asthmatic events occurring the 48 hours after immunotherapy injections had been administered were considered a possible consequence of immunotherapy (immediate or late allergic reaction). Immediate type reactions were defined as any allergic reaction occurring within 2 hours after the injections.
Frequency Threshold: 0
Time Frame: Adverse event data was collected during the 3-year study period.
Study: NCT01028560
Study Brief: Allergy Immunotherapy for the Reduction of Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Immunotherapy, Receive Standard of Care Asthma Treatment This group consists of children who do not receive allergy immunotherapy. Both groups - the experimental as well as the control group receive otherwise standard of care asthma and allergy treatment Standard of care: standard of care asthma and allergy treatment 0 None 7 23 0 23 View
Allergen Immunotherapy This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment Allergen extracts (subcutaneous injections): Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-3 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase. Standard of care: standard of care asthma and allergy treat 0 None 6 27 22 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma related hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis/skin abscess/infected insect bite NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local allergic reaction after immunotherapy injectionss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Systemic allergic reactions after immunotherapy injections NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View