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 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:26 AM
NCT ID: NCT00848120
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded from the date of screening until 4 weeks after the last infusion.
Study: NCT00848120
Study Brief: A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients 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
Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks. None None 1 29 24 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated ALT/SGPT level NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Elevated AST ad ALT levels NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Urinary tract infection (UTI) NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Systemic viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Non ulcer dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pruritic back NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritic, erythematous scaly plaques over interdigital areas (right foot, first-third toes) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rashes on chest: back NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rashes on toes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythematous, pruritic maculopapular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Contact dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Carpal tunnel syndrome (R) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Trigger finger 4th digit left hand NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Uterine myoma with nabothian cysts NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paresthesia at the palm of infusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Knee effusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Chills and increased pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache/back pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever and headache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough productive due to infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute pharyngitis probably viral etiology NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dengue NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Folliculitis left ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Elevated AST/SGOT level NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Fatty liver NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Internal hemorrhoids, grade 1 NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View