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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT00627393
Description: Serious adverse events and other adverse events (i.e. granulocyte transfusion related events) data were collected. The number of participants at risk for other adverse events corresponds to the number of participants who received granulocyte transfusions (6 control arm subjects and 51 granulocyte arm subjects).
Frequency Threshold: 0
Time Frame: Serious adverse events were reported up to 42 days after randomization.
Study: NCT00627393
Study Brief: Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Granulocyte Arm Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy. None None 26 56 32 51 View
Control Arm Received antimicrobial therapy alone. None None 25 58 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal symptom NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated partial thromboplastin time shortened NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute lung injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased blast cell count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased blood creatinine NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cytomegalovirus viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fungaemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastric haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Graft versus host disease NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hallucination NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hydraemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalaemic syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection in an immunocompromised host NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Metabolic disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Multi-organ failure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic abscess NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased prothrombin level NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis neonatal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemolysis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rigors and Chills NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction/ hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View