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 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT01999192
Description: All adverse events have been matched in accordance with the dosing under which they occurred. This resulted in a higher number of subjects at risk, because some subjects received two dosages. Patients who responded at week 12 continued the same treatment for 12 weeks and non-responders at week 12 were escalated to the next higher dose level or re-randomized to active treatment (placebo patients). After 24 weeks, placebo patients were switched to active treatment during the Extension Phase.
Frequency Threshold: 5
Time Frame: through study completion, up to 1 year
Study: NCT01999192
Study Brief: Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active 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
25mg Dose Level 1 Tregalizumab Dose Level 1 Tregalizumab (25mg) None None 3 105 14 105 View
100mg Dose Level 2 Tregalizumab Dose Level 2 Tregalizumab (100mg) None None 1 117 16 117 View
200mg Dose Level 3 Tregalizumab Dose Level 3 Tregalizumab (200mg) None None 7 122 15 122 View
Placebo Placebo - None None 1 80 9 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Multiple Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Shock Haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Flavivirus Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.1) View
Multiple Sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Frostbite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Generalised Tonic-Clonic Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Lichen Planus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View