TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01735201

Adverse event: Application site acne
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Event not related to study treatment.
Frequency: 1 affected / 44 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Application site acne
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Application site acne
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Event not related to study treatment.
Frequency: 1 affected / 44 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Event not related to study treatment.
Frequency: 1 affected / 44 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Event not related to study treatment.
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Event not related to study treatment.
Frequency: 1 affected / 45 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Application site acne
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Application site acne
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk
Study: NCT01735214

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 358 at risk
Study: NCT01735396

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

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

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

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

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Alkaline phosphatase level increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 10 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 10 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 10 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Muscle weakness in lower limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Aspartate aminotransferase level increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Alanine aminotransferase level increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk
Study: NCT01735617

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 16 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 16 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 16 at risk

Adverse event: Appetite increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 16 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 16 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk
Study: NCT01735916

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Lead dislodgement
Frequency: 1 affected / 7 at risk

Adverse event: Enterocolitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk
Study: NCT01736124

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Pt suffered a mild stroke and was hospitalized. Pt was withdrawn from the study
Frequency: 1 affected / 90 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: death reported by relative in phone contact
Frequency: 3 affected / 90 at risk

Adverse event: Surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Scheduled surgery on stomach. Participants were not withdrawn from the study..
Frequency: 2 affected / 90 at risk

Adverse event: Surgery
Serious: yes
Organ System: Immune system disorders
Notes: Participant had scheduled surgery related to gout and was not withdrawn from the study.
Frequency: 1 affected / 90 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: death reported by relative in phone contact
Frequency: 3 affected / 90 at risk
Study: NCT01736267

Adverse event: Headache, photophobia, stiff neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: clear AD drainage
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3 at risk

Adverse event: CSF collection
Serious: no
Organ System: General disorders
Notes: CSF collection with mild swelling post-surgery
Frequency: 1 affected / 3 at risk

Adverse event: non-auditory side effects
Serious: no
Organ System: Nervous system disorders
Notes: non-auditory side effects after turning on device - "pinching" sensation in the leg
Frequency: 1 affected / 3 at risk
Study: NCT01736475

Adverse event: Herpes zoster infection neurological
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 137 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 137 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 137 at risk

Adverse event: Neuroendocrine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 137 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 137 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 137 at risk
Study: NCT01736527

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Non-Ocular Treatment-Emergent Adverse Events Population: Safety
Frequency: 1 affected / 12 at risk
Study: NCT01736566

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Notes: Elevated HADS scale anxiety score
Frequency: 3 affected / 50 at risk

Adverse event: Serious
Serious: yes
Organ System: Cardiac disorders
Notes: Deceased- Complications of Cardiomyopathy
Frequency: 3 affected / 50 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Learned that participant had died when called to collect long term follow-up data. Cause of death from medical record review appears to be a stroke. Not related to the intervention
Frequency: 3 affected / 50 at risk

Adverse event: Serious
Serious: yes
Organ System: Cardiac disorders
Notes: Deceased- Complications of Cardiomyopathy
Frequency: 1 affected / 52 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Learned that participant had died when called to collect long term follow-up data. Cause of death from medical record review appears to be a stroke. Not related to the intervention
Frequency: 1 affected / 52 at risk
Study: NCT01736579

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT01736657

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 72 at risk
Study: NCT01736696

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT01736852

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization
Frequency: 1 affected / 63 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization
Frequency: 1 affected / 63 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 1 Life Threatening, 1 Hospitalization
Frequency: 2 affected / 63 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization
Frequency: 1 affected / 63 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Congenital Abnormality or birth defect
Frequency: 1 affected / 63 at risk

Adverse event: Arrested labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 63 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 63 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 63 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization
Frequency: 1 affected / 61 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization
Frequency: 1 affected / 61 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Life Threatening
Frequency: 1 affected / 61 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization
Frequency: 1 affected / 61 at risk

Adverse event: Arrested labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 61 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 61 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 61 at risk
Study: NCT01736865

Adverse event: New or prolonged hospitalization
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Adverse event
Serious: no
Organ System: General disorders
Frequency: 24 affected / 61 at risk

Adverse event: New or prolonged hospitalization
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 66 at risk

Adverse event: Adverse event
Serious: no
Organ System: General disorders
Frequency: 17 affected / 66 at risk
Study: NCT01737281

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 39 affected / 969 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 27 affected / 969 at risk

Adverse event: Life-threating event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 969 at risk
Study: NCT01737684

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk
Study: NCT01737710

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk
Study: NCT01737879

Adverse event: Ventricular asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 34 at risk
Study: NCT01737931

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 120 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 3 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 120 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 120 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 120 at risk
Study: NCT01737944

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE Occurred During Treatment A
Frequency: 1 affected / 9 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: AE Occurred During Treatment A
Frequency: 1 affected / 9 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: AE Occurred During Treatment B
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: AE Occurred During Treatment B
Frequency: 1 affected / 9 at risk
Study: NCT01738191

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Jitters
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Syncopal Episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Decreased memory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk