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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00886795
Description: Adverse events were collected by patient report at each study visit in response to open ended questioning.
Frequency Threshold: 0
Time Frame: 3 years
Study: NCT00886795
Study Brief: Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abatacept 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of \>60 kg, 60-100kg, or 100 kg respectively. None None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Rheum CTCAE v2.0 View
Common Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rheum CTCAE v2.0 View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rheum CTCAE v2.0 View
Diastasis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Rheum CTCAE v2.0 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations Rheum CTCAE v2.0 View
Hypoesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Rheum CTCAE v2.0 View
Right Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Rheum CTCAE v2.0 View
Rhinorrhea SYSTEMATIC_ASSESSMENT General disorders Rheum CTCAE v2.0 View
Sinus Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rheum CTCAE v2.0 View
Tinea Pedis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Rheum CTCAE v2.0 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rheum CTCAE v2.0 View