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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT03394508
Description: None
Frequency Threshold: 0
Time Frame: Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.
Study: NCT03394508
Study Brief: The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With 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
Placebo ALK diluent 0,3% human albumin' ALK diluent 0.1 ml human albumin: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval 0 None 0 13 5 13 View
Active Treatment Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension ALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection before the second pollen season. 0 None 2 17 13 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Generalized urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sarcoidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchyness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swollen locally around injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tiredness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View