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 @ 9:49 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT02225132
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02225132
Study Brief: Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hydroxyurea Hydroxyurea is given to the patients as per a dosing algorithm. 0 None 3 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute chest syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sickle cell anaemia with crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View