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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT01194804
Description: None
Frequency Threshold: 5
Time Frame: From baseline (after first dose) to end of study (1 year).
Study: NCT01194804
Study Brief: E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria 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
Eculizumab Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol 900 mg intravenous every 14 days. 0 None 12 27 26 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemolysis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Jaundice cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View