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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT01895335
Description: Reported AEs are TEAEs that is AEs that developed/worsened from first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants in AEP. Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All AEs were collected from signature of the informed consent form up to the last visit (Week 52) regardless of seriousness or relationship to investigational product.
Study: NCT01895335
Study Brief: Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Teriflunomide Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks. None None 127 1000 498 1000 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Blindness Unilateral SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Retinal Artery Thrombosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal Hernia Obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Intervertebral Disc Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Invasive Ductal Breast Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Malignant Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Non-Small Cell Lung Cancer Stage Iv SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Hypertonic Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Colitis Microscopic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Biliary Colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Clostridium Difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Myelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oesophageal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pelvic Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Perichondritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Clostridium Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Fibrin D Dimer Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Metabolic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Cervical Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Fibroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Rectal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebral Sarcoidosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cervicobrachial Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Medication Overuse Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Multiple Sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Multiple Sclerosis Relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Neuromyelitis Optica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Toxic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Trigeminal Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Uhthoff's Phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 18.1 View
Acute Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Adjustment Disorder With Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Female Genital Tract Fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Acute Interstitial Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Asthmatic Crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Lung Cyst SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Abdominoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Essential Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View