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 @ 4:59 PM
Ignite Modification Date: 2025-12-25 @ 2:40 PM
NCT ID: NCT01359150
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 2
Time Frame: None
Study: NCT01359150
Study Brief: A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CP-690,550 + Influenza and Pneumococcal Vaccine CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. None None 4 112 17 112 View
Placebo + Influenza and Pneumococcal Vaccine Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice. None None 1 111 17 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View