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 @ 11:46 PM
Ignite Modification Date: 2025-12-25 @ 9:39 PM
NCT ID: NCT05576051
Description: Due to non-interventional nature of the study and nature of data sources, the minimum criteria for reporting an adverse event (that is, identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence adverse events were not planned to be evaluated (thus at risk appears "0").
Frequency Threshold: 0
Time Frame: Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study.
Study: NCT05576051
Study Brief: To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TNFi Initiators After 11/6/2012 Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
All TNFi Initiators Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
All TNFi Initiators Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
TNFi Initiators After 11/6/2012 Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
Tofacitinib Initiators Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
Tofacitinib Initiators Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):