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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT00860405
Description: Regular assessment by Pharmacovigilance and Safety Assessor
Frequency Threshold: 0
Time Frame: Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).
Study: NCT00860405
Study Brief: Voluven® in Paediatric 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
Voluven® Arm 6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid. None None 11 31 30 31 View
HSA 5% Arm (Comparison Group) Human Serum Albumin (HSA) 50g/L, i.v. None None 7 29 29 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 13.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Internal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View
Device breakage SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Medical device complication SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Post procedural pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Urinary tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Cardiac procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 13.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 13.0 View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 13.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 13.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Cardiac aneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Exposure to contaminated device SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Infusion site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 13.0 View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
H1n1 Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Post procedural pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 13.0 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Cardiac procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Dilutional coagulopathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Procedural vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Blood lactic acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Enterovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Venous oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hyperlactacidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 13.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 13.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 13.0 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 13.0 View
Phrenic nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 13.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 13.0 View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 13.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Bradypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 13.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Increased bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Respiratory depression SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 13.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Pruritus allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 13.0 View
Arterial thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 13.0 View
Nodal rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 13.0 View