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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT01548768
Description: An adverse event (AE) is any undesirable sign, symptom or medical condition occurring after starting study drug (or therapy). Medical conditions/diseases present before starting study treatment are only considered adverse events if they worsen after starting study therapy. In addition all adverse events regardless of whether they constitute unanticipated problems as well as AEs thought to be possibly related to study procedures will also be reported to IRB, safety officer, SMC, and NIH/NIAMS.
Frequency Threshold: 0
Time Frame: For those who underwent the baseline scans only (RA cross-sectional cohort, Healthy Controls), the gathering of adverse events were determined from the events from the visit alone (either acute, or patient-reported follow-up); For the group escalated in treatment therapy (n=12), adverse events were collected from baseline visit/randomization to the end-of-study safety visit conducted 6-8 weeks after the 6-month study visit.
Study: NCT01548768
Study Brief: RHYTHM (Formerly Escape II Myocardium)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RA Patients - Pharmacotherapy Escalation (TNFi) Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care. TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade, 0 None 1 8 1 8 View
RA Patients - Pharmacotherapy Escalation (DMARD) Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs. 0 None 0 4 0 4 View
Healthy Volunteers Subjects without RA who will function as controls. 0 None 0 16 0 16 View
Patients - Cross Sectional (RA) A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis. 0 None 0 121 6 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Shortness Of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsening Migraine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mobitz II Heart Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina NON_SYSTEMATIC_ASSESSMENT General disorders None View
Atrial Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Panic Attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View