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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT02267135
Description: None
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT02267135
Study Brief: Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Secukinumab 300 mg None None 0 51 8 51 View
Treatment Period 1 Placebo Treatment Period 1 Placebo None None 1 51 5 51 View
Treatment Period 2 Placebo/Secukinumab 300 mg Treatment Period 2 Placebo/Secukinumab 300 mg None None 1 46 5 46 View
Treatment Period 1 & 2: Any Secukinumab None None None 1 96 5 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View