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: 2025-12-24 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT01720251
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01720251
Study Brief: Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
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 All patients having received at least one injection of Placebo (Safety Set) None None 0 79 59 79 View
Allert 50 µg All patients having received at least one injection of Allert 50 µg (Safety Set) None None 1 78 70 78 View
AllerT 100 µg All patients having received at least one injection of Allert 100 µg (Safety Set) None None 2 82 70 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders conjunctivitis View
Oropharyngeal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Oropharyngeal discom View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Skull fracture View
Tongue oedema NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Tongue oedema View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Urticaria View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT General disorders Hypersensitivity View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Nasopharyngitis View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rhinitis View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Dyspnea View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders Conjunctivitis View
Injection site oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Injection site oedem View
Injection site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Injection site pain View
Injection site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Injection site react View
Injection site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Injection site eryth View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Cough View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Pruritus View