TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01244061

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 249 at risk

Adverse event: Allergy to chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 249 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 249 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 249 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 249 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 249 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 249 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 249 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 249 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 249 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 249 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 249 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 249 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 249 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 245 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 245 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 245 at risk

Adverse event: Hyperventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 245 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 245 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 245 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 245 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 245 at risk
Study: NCT01244451

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 49 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 49 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Other toxicity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk
Study: NCT01244503

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Upper right quadrant pain
Frequency: 1 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Non liver related
Frequency: 1 affected / 61 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 61 at risk

Adverse event: Odiferous breath
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk
Study: NCT01244633

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 18 at risk
Study: NCT01244724

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk
Study: NCT01244737

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: urticaria
Frequency: 1 affected / 16 at risk

Adverse event: Intracranial tumour haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: intracranial tumor hemorrhage
Frequency: 1 affected / 28 at risk

Adverse event: reversible posterior leukoencephalopathy sydrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk
Study: NCT01245049

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 127 affected / 255 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 146 affected / 255 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 92 affected / 255 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 77 affected / 255 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 107 affected / 255 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 67 affected / 255 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 18 affected / 255 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 70 affected / 130 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 73 affected / 130 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 53 affected / 130 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 39 affected / 130 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 49 affected / 130 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 30 affected / 130 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 9 affected / 130 at risk
Study: NCT01245101

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk
Study: NCT01245283

Adverse event: Subject inability to complete the maximum exercise test
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study
Frequency: 2 affected / 32 at risk

Adverse event: Subject inability to complete the maximum exercise test
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study
Frequency: 2 affected / 28 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Subject inability to complete the maximum exercise test
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study
Frequency: 1 affected / 30 at risk
Study: NCT01245439

Adverse event: Hypertension, tremor, acute infusion reaction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pneumonia (community acquired pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pneumonia (suspected)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Vasculit (splinter hemorrhage, fingertip hemorrhage)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypercholesterolaemia, Hypertriglyceridaemia, LDL-Hyperlipidaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Elevated levels of ALT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Cardiac pain (angina pectoris)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 65 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 65 at risk

Adverse event: Elevated ALT <45
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 65 at risk

Adverse event: Elevated ALT 1.5- 3 ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 65 at risk

Adverse event: Elevated AST <60
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 65 at risk

Adverse event: Elevated AST 1.5 - 3ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 65 at risk
Study: NCT01245595

Adverse event: Low Cardiac Output requiring Cardiopulmonary resuscitation or Extracorporeal Membrane Oxygenation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk

Adverse event: Junctional ectopic tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 72 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Unspecified Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Acute Kidney Injury (AKI)
Serious: no
Organ System: Renal and urinary disorders
Notes: Managing physician treated AKI with aminophylline out of protocol
Frequency: 1 affected / 72 at risk

Adverse event: Low Cardiac Output requiring Cardiopulmonary resuscitation or Extracorporeal Membrane Oxygenation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Cardiac Arrhythmia Leading to Cardiopulmonary Resuscitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Junctional ectopic tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk

Adverse event: Ectopic Atrial Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Unspecified Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Acute Kidney Injury (AKI)
Serious: no
Organ System: Renal and urinary disorders
Notes: Managing physician treated AKI with aminophylline out of protocol
Frequency: 1 affected / 72 at risk

Adverse event: Pulmonary Hypertension with low cardiac output
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Arm and jaw pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk
Study: NCT01245647

Adverse event: diarrhea/upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Muscle spasm/diarrhea/anxiety
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle spasms every few minutes, diarrhea, urinary incontinence, anxiety, restlessness and SOB. Was admitted for observation 4-20-11 and discharged 4-22-11. The ER Physician remarked that it was not likely due to naltrexone.
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: diarrhea/upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 12 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 12 at risk
Study: NCT01245738

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 474 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 474 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 474 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 474 at risk
Study: NCT01245972

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 8 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 8 at risk
Study: NCT01246011

Adverse event: Hypotension after Coronary Artery Bypass Graft Surgery
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 8 at risk

Adverse event: Atrial Fibrillation after Coronary Artery Bypass Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8 at risk

Adverse event: Bleeding during or immediately after Coronary Artery Bypass Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Low Hematocrit after Coronary Artery Bypass Graft Surgery
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 8 at risk

Adverse event: Urinary Retention after Coronary Artery Bypass Surgery
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Post operative nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Parkinson's-like features
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01246401

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Decreased Apetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Increased Apetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 66 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Signs of Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Immediate Injection Reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Decreased Apetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Increased Apetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Signs of Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Immediate Injection Reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk
Study: NCT01246479

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk
Study: NCT01246791

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 12 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk