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 @ 1:59 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT00727194
Description: TEAEs were collected at every visit and follow-up
Frequency Threshold: 0
Time Frame: 46 weeks (Screening Period [up to 4 weeks], Treatment Period 1 [16 weeks], Washout Period [5 weeks], Treatment Period 2 [16 weeks], Follow-up Period [5 weeks]) for adverse events (AEs); 42 weeks for treatment emergent AEs (TEAEs).
Study: NCT00727194
Study Brief: Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
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 Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1. None None 1 13 11 13 View
Eculizumab Eculizumab Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1. None None 1 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myasthenia Gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Myasthenia Gravis Crisis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Eye Discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Lip Dry SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Oesophageal Food Impaction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Salivary Gland Enlargement SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Application Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Vessel Puncture Site Haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hepatic Steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Oral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Procedural Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Tendon Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Tooth Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Heart Rate Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Acrochordon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Cholinergic Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Sensory Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Menstrual Disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Polymenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory Tract Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dermatitis Allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus Generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View