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: 2025-12-25 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT03449758
Description: Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug.
Study: NCT03449758
Study Brief: Effect of Sarilumab on Patient-reported Outcomes in Patients 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
Sarilumab Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to 39.7 weeks. 0 None 10 84 54 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Interstitial Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View