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 @ 11:49 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT00414661
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: NCT00414661
Study Brief: Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
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 >=10 mg Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies. None None 0 48 3 48 View
CP-690,550 <10 mg Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies. None None 1 89 2 89 View
Placebo Participants who had received 1 dose of matching-placebo in any of the previous studies. None None 0 22 1 22 View
Adalimumab Participants who had received 1 dose of adalimumab in any of the previous studies. None None 0 3 0 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v14.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v14.1 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v14.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v14.1 View