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 @ 6:29 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT00896168
Description: None
Frequency Threshold: 2
Time Frame: Baseline up to Week 26
Study: NCT00896168
Study Brief: An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab + Methotrexate (Moderate RA) Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. None None 2 104 57 104 View
Infliximab + Methotrexate (Severe RA) Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks. None None 2 130 80 130 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fungal pneumonia NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Septicemia NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Cardiac disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tuberculosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hepatic function disnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypolekocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View