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 @ 1:58 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT02029495
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02029495
Study Brief: Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
210 mg Brodalumab Administered via subcutaneous injections 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection None None 10 158 84 158 View
140 mg Brodalumab Administered via subcutaneous injection 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection None None 5 158 79 158 View
Placebo Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24. None None 4 159 71 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Squimos Cell Carcinoma of the Vulva NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant Melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Major Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lens Dislocation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Drug reaction with Eosinaphilia and Systematic symptoms NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Synovial Cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral Disc protusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Psoriatic Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Eye Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Iris Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Keratorhexis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrheoa NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Psoriatic Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Major Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Spinal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Odema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Odema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blood Pressure Increased NON_SYSTEMATIC_ASSESSMENT Investigations None View