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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT01212094
Description: First 12 months (Month -12 to Month 0), all patients were untreated; next 24 months (Month 0 to Month 24) patients were randomized to placebo or active treatment
Frequency Threshold: 0
Time Frame: 36 months
Study: NCT01212094
Study Brief: Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo group None None 4 9 9 9 View
Rituximab Group who got active drug None None 4 18 18 18 View
Baseline Patients in their first year baseline prior to study drug phase None None 0 43 8 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cognitive Decline SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated Blood Sugar SYSTEMATIC_ASSESSMENT Endocrine disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Post LP Headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neck and Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gallstones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea/Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Enhancing brain lesion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated Liver Enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Teeth Cracking SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lipoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Trigeminal Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
bunionectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fungal Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shoulder Dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Torn Meniscus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dislocated Shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medication Refill SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View