TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02576054

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 31 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 100 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 34 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 100 at risk
Study: NCT02576067

Adverse event: Missinjected dose (isotope)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Missinjected dose (isotope)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 63 at risk
Study: NCT02576652

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT02576847

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Post concussion syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 307 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 307 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 307 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 307 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 307 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 307 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 307 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 307 at risk
Study: NCT02576860

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 136 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 136 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 136 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 136 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 136 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 136 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 127 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 127 at risk
Study: NCT02577003

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 73 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 73 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 70 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 70 at risk
Study: NCT02577016

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 70 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 70 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 71 at risk
Study: NCT02577042

Adverse event: increments of creatine kinase
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: increment of liver enzymes
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk
Study: NCT02577107

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infectious pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Fracture of jaw
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Fracture of rib
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Pulmonary contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Thoracic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT02577445

Adverse event: Acute Reneal Failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: One subject suffered from postoperative acute renal failure due to contrast fluid exposition at implant procedure
Frequency: 1 affected / 17 at risk

Adverse event: Cardiac Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cardiac/cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Other cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 17 at risk

Adverse event: Lead Dislocation
Serious: yes
Organ System: Product Issues
Notes: lead dislocations led to a system modification which was successful in all three patients, with one patient needing two modifications to achieve stable lead position
Frequency: 3 affected / 17 at risk

Adverse event: Diaphragm stimulation discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Cardiac decompensation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: beginning liver insufficiency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Lead Dislocation
Serious: no
Organ System: Product Issues
Notes: 1 lead dislocation was not reported as SAE by site
Frequency: 1 affected / 17 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk
Study: NCT02577510

Adverse event: Femoral Block
Serious: no
Organ System: Nervous system disorders
Notes: femoral nerve block
Frequency: 1 affected / 21 at risk
Study: NCT02577523

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Panniculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 11 affected / 19 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infusion site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening
Frequency: 1 affected / 19 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 7 affected / 19 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Infusion site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening
Frequency: 2 affected / 19 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 19 at risk
Study: NCT02577601

Adverse event: Butterfly rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One subject reported a significant malar rash several hours after UPA dosing in Cycle 1 that resolved on its own and did not reoccur with UPA dosing in Cycle 3.
Frequency: 1 affected / 36 at risk
Study: NCT02577718

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient Rash, occurred after 23rd dose, resolved
Frequency: 1 affected / 60 at risk

Adverse event: Headache (transient)
Serious: no
Organ System: Nervous system disorders
Notes: Mild, Transient Headache reported after 4th of 5 doses, resolved.
Frequency: 1 affected / 60 at risk
Study: NCT02577835

Adverse event: Transient Ischemic Attack (TIA) or stroke (ischemic or hemorragic)
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 591 at risk

Adverse event: Myocardial infarction, angina pectoris, or coronary revascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 591 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 591 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 591 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 591 at risk
Study: NCT02578186

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: General 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: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 29 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk
Study: NCT02578706

Adverse event: Cholecystitis
Serious: yes
Organ System: Infections and infestations
Notes: not related to study drug
Frequency: 1 affected / 10 at risk
Study: NCT02578732

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac disorder, other
Serious: yes
Organ System: Cardiac disorders
Notes: Takotsubo cardiomyopathy
Frequency: 1 affected / 28 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 25 affected / 28 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 28 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 28 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 28 at risk

Adverse event: Elevated AST/ALT
Serious: no
Organ System: Investigations
Frequency: 12 affected / 28 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 20 affected / 28 at risk
Study: NCT02578745

Adverse event: Pruiritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk
Study: NCT02578914

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Transient and self-limiting instillation site irritation that resolved in all cases.
Frequency: 49 affected / 50 at risk

Adverse event: Lacrimination increased
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 50 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 50 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Transient and self-limiting instillation site irritation that resolved in all cases.
Frequency: 4 affected / 50 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 50 at risk
Study: NCT02579057

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Notes: Serum potassium \< 3.5 mEq/L
Frequency: 1 affected / 21 at risk