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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT04752566
Description: Safety set included all participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Day 1 up to Week 24
Study: NCT04752566
Study Brief: A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eculizumab Participants received eculizumab IV infusion on Days 1, 8, 15, and 22. 1 None 4 37 34 37 View
Placebo Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22. 0 None 1 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hanging NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Chronic inflammatory demyelinating polyradiculoneuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v25.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Genital candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Fibrin D dimer increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Protein urine NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Lumbar radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Genital rash NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v25.0 View
Sputum retention NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Skin erosion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Asteatosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Eczema asteatotic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25.0 View
Venous thrombosis limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25.0 View