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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT01439204
Description: None
Frequency Threshold: 5
Time Frame: Day 1 to Day 71
Study: NCT01439204
Study Brief: Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
750 mg Abatacept From Devens, MA A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. None None 0 36 11 36 View
750 mg Abatacept From Lonza, NH A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes. None None 0 36 12 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View