TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00283400

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Symptomatic Cerebral Vasospasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Rebleeding
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gram-negative ventriculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypotension due to sepsis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Severe or life-threatening acute heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Symptomatic Cerebral Vasospasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Severe or life-threatening acute heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: Symptomatic Cerebral Vasospasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk
Study: NCT00283595

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Polyuria
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 10 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Irritation at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Paresthesias (carpal tunnel symptoms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Irritation at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Polydipsia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT00283803

Adverse event: Gallstone with cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: One patient was hospitalized from loss of consciousness and was ultimately diagnosed with pneumonia. The patient was discharged after 1 day and it was determined that this event was not related to the study drug.
Frequency: 1 affected / 32 at risk

Adverse event: Elevated LFTs
Serious: no
Organ System: Investigations
Frequency: 10 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 32 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Congested Sinuses/Cold
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 32 at risk

Adverse event: Hypertriglyceridemia/Hyperlipidemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 32 at risk

Adverse event: Pain/Soreness/Cramps - leg(s)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 32 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 32 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 32 at risk
Study: NCT00283933

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Scrotal mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT00283959

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bifascicular block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: QRS axis abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Venous pressure jugular increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Poor peripheral circulation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk
Study: NCT00285207

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 75 at risk
Study: NCT00285649

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 72 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 72 at risk

Adverse event: Pain/stiffness in the extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 48 at risk
Study: NCT00285818

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Headache was of mild severity, related to non-specific muscle tension in the temporal and occipital area.
Frequency: 1 affected / 6 at risk
Study: NCT00285857

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT00286156

Adverse event: nephrotic range proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Open renal biopsy showed FSGS. Primary glomerulopathies have been reported to be superimposed on underlying ADPKD.
Frequency: 1 affected / 10 at risk

Adverse event: Decrease visual acuity
Serious: yes
Organ System: Eye disorders
Notes: Patient developed transient decrease in visual acuity. Neuro-ophthalmologist did not find any association with drug. Vision improved without specific treatment.
Frequency: 1 affected / 10 at risk

Adverse event: Oral ulcerations
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 10 at risk

Adverse event: Nonserious infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Miscellaneous/other
Serious: no
Organ System: General disorders
Notes: The problems in this group were minor, extremely varied and transient.
Frequency: 4 affected / 10 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient had massive polycystic kidneys (about 7500ml) and there was compression of the right iliac vein/IVC with clot formation. This has been reported in the literature, so it is not necessarily related to drug.
Frequency: 1 affected / 10 at risk

Adverse event: Oral ulcerations
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nonserious infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Miscellaneous/other
Serious: no
Organ System: General disorders
Notes: The problems in this group were minor, extremely varied and transient.
Frequency: 2 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia associated with excessive beer consumption.
Frequency: 1 affected / 10 at risk

Adverse event: Nonserious infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Miscellaneous/other
Serious: no
Organ System: General disorders
Notes: The problems in this group were minor, extremely varied and transient.
Frequency: 5 affected / 10 at risk
Study: NCT00286182

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 28 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalized
Frequency: 3 affected / 28 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 28 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: Sudden death unrelated to the treatment: Subject was vacationing and collapsed on a beach and died suddenly. No cause of death was determined.
Frequency: 1 affected / 28 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalized
Frequency: 2 affected / 28 at risk
Study: NCT00286728

Adverse event: Died
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 142 at risk

Adverse event: Incarcerated
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 142 at risk

Adverse event: Died
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 145 at risk

Adverse event: Incarcerated
Serious: yes
Organ System: Social circumstances
Frequency: 3 affected / 145 at risk
Study: NCT00286741

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: All-Cause hospitalization
Serious: yes
Organ System: General disorders
Frequency: 56 affected / 133 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Patient self-report, or blood glucose measured \< 60
Frequency: 101 affected / 133 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Systolic Blood Pressure \< 100
Frequency: 19 affected / 133 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: Patient self-report
Frequency: 66 affected / 133 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Decrease in estimate Glomerular Filtration Rate \> 10 ml/min/1.73 m2
Frequency: 71 affected / 133 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Notes: Aspartate aminotransferase or alanine aminotransferase \> 50 U/liter
Frequency: 2 affected / 133 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: All-Cause hospitalization
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 106 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Patient self-report, or blood glucose measured \< 60
Frequency: 83 affected / 106 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Systolic Blood Pressure \< 100
Frequency: 14 affected / 106 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: Patient self-report
Frequency: 62 affected / 106 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Decrease in estimate Glomerular Filtration Rate \> 10 ml/min/1.73 m2
Frequency: 51 affected / 106 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Notes: Aspartate aminotransferase or alanine aminotransferase \> 50 U/liter
Frequency: 2 affected / 106 at risk
Study: NCT00286754

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 176 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 176 at risk

Adverse event: Multiple fractures
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 176 at risk

Adverse event: torn ligament
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 176 at risk

Adverse event: Coronary artery bypass
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 176 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 177 at risk

Adverse event: Multiple fractures
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 177 at risk

Adverse event: Hypertensive emergency
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 177 at risk

Adverse event: Coronary artery bypass
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 177 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 180 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 180 at risk

Adverse event: Multiple fractures
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: torn ligament
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 180 at risk

Adverse event: Hypertensive emergency
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 180 at risk