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 @ 10:44 PM
Ignite Modification Date: 2025-12-25 @ 8:14 PM
NCT ID: NCT01597635
Description: The All subjects population was used for analysis.
Frequency Threshold: 5
Time Frame: Upto follow-up Day 7.
Study: NCT01597635
Study Brief: The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days. 3 None 3 5 5 5 View
Part B (Placebo BID) Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days. 2 None 4 20 14 20 View
Part B (GSK2586881 BID) Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days. 1 None 3 19 15 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bronchial anastomosis complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Food intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Increased upper airway secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blood blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pH increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candiduria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasal herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Penis injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Scrotal erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Endotracheal intubation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View