TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02505217

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: myocardial infarction
Frequency: 3 affected / 93 at risk

Adverse event: revascularization
Serious: yes
Organ System: Cardiac disorders
Notes: coronary revascularization
Frequency: 3 affected / 93 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: myocardial infarction
Frequency: 7 affected / 104 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: stroke
Frequency: 3 affected / 104 at risk

Adverse event: mortality
Serious: yes
Organ System: Investigations
Notes: all cause mortality
Frequency: 3 affected / 104 at risk

Adverse event: revascularization
Serious: yes
Organ System: Cardiac disorders
Notes: coronary revascularization
Frequency: 4 affected / 104 at risk
Study: NCT02505334

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 233 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 233 at risk

Adverse event: Large intestinal polypectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 233 at risk

Adverse event: Prostatic specific antigen increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 233 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Squamous cell carcinoma of the vagina
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 233 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 233 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 233 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 233 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 233 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 233 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 233 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 233 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 233 at risk
Study: NCT02505984

Adverse event: Uterine Cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Slight nosebleeding
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Uterine Cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Slight nosebleeding
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: Participant reported tightness in chest (unknown effect) after 1 dose; she was unsure if related to nasal spray. Event reported to Institutional Review Board (expedited review). Study blind was opened and identified participant as randomized placebo.
Frequency: 1 affected / 22 at risk
Study: NCT02506101

Adverse event: Redness of the skin area in both axillae (armpit)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT02506244

Adverse event: Skin irritation from Zio XT patch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minor skin irritation that resulted from wearing the patch. All resolved.
Frequency: 20 affected / 908 at risk

Adverse event: Skin irritation from Zio XT patch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minor skin irritation that resulted from wearing the patch. All resolved.
Frequency: 21 affected / 834 at risk
Study: NCT02506465

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: One case Injury relates to poisoning and procedural complications and the second one relates to renal and urinary disorders
Frequency: 2 affected / 128 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 128 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 128 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One patient died from an unrelated pancreatic cancer complication.
Frequency: 1 affected / 128 at risk

Adverse event: General weakness
Serious: yes
Organ System: General disorders
Notes: General system disorders NEC
Frequency: 2 affected / 128 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea and vomiting symptoms
Frequency: 2 affected / 128 at risk

Adverse event: Depression, suicidal and self-injurious behavior
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 128 at risk

Adverse event: Abscess and sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 128 at risk

Adverse event: Deep vein thrombosis (DVT) of legs
Serious: yes
Organ System: Vascular disorders
Notes: Peripheral embolism and thrombosis
Frequency: 1 affected / 128 at risk

Adverse event: Shoulder fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Upper limb fractures and dislocations
Frequency: 1 affected / 128 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 128 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 128 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 128 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 57 at risk
Study: NCT02506634

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: There was one serious adverse event (SAE) that a patient had pneumothorax during the treatment phase and withdrew from the study, which had no causality with any drug or study procedure.
Frequency: 1 affected / 357 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 357 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 357 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 357 at risk

Adverse event: Bitter taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 357 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 357 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 357 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 357 at risk
Study: NCT02506816

Adverse event: Post-surgical wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 36 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk
Study: NCT02507011

Adverse event: HF Exaceberation/Electrolyte Imbalance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: HF Exaceberation/Electrolyte Imbalance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT02507297

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 16 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hyperbilirubinemia in participant's infant requiring hospitalization of infant
Frequency: 1 affected / 16 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation specifically related to CPAP mask
Frequency: 5 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry mouth specifically related to CPAP usage
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal congestion specifically related to CPAP usage
Frequency: 1 affected / 16 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Notes: Claustrophobia when using CPAP mask
Frequency: 2 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia specifically related to using CPAP or to in-lab sleep night (only PAP participants completed the in-lab sleep night)
Frequency: 2 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening of depression from baseline
Frequency: 4 affected / 16 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Gestational diabetes
Frequency: 2 affected / 16 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening of depression from baseline
Frequency: 3 affected / 13 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Gestational diabetes
Frequency: 1 affected / 13 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 13 at risk

Adverse event: Small for gestational age (infant)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant's infant was small for gestational age
Frequency: 1 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Distress/anxiety in completing study questionnaires
Frequency: 1 affected / 13 at risk
Study: NCT02507388

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

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 25 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 25 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vitreal cells
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk
Study: NCT02507934

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT02507960

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 17 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 17 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 17 at risk

Adverse event: Breast pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 17 at risk

Adverse event: Limb Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT02507973

Adverse event: Increased systolic blood pressure
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: One patient enrolled in the trial had a spike in systolic blood pressure to just above 300 mmHg when switched to APRV. The trial immediately terminated in this patient, and the systolic blood pressure returned to within normal limits.
Frequency: 1 affected / 8 at risk

Adverse event: Increased systolic blood pressure
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: One patient enrolled in the trial had a spike in systolic blood pressure to just above 300 mmHg when switched to APRV. The trial immediately terminated in this patient, and the systolic blood pressure returned to within normal limits.
Frequency: 1 affected / 8 at risk
Study: NCT02508077

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

Adverse event: blood anion gap decreased.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

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

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

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk
Study: NCT02508103

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild headache reported by two participants during oxytocin administration.
Frequency: 2 affected / 10 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Mild uterine cramping reported by two participants during oxytocin administration.
Frequency: 2 affected / 10 at risk

Adverse event: Clogged nostril
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported one nostril became slightly clogged during intranasal Placebo administration.
Frequency: 1 affected / 10 at risk
Study: NCT02508207

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 27 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk
Study: NCT02508259

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

Adverse event: Upper respiratory tract infection (URI)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: In 7-year old after pizza and slushee consumption after playing youth league basketball, and in a 6-year old after a car ride.
Frequency: 1 affected / 5 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Both cases occurred 6-weeks after the infusion, after several days of a URI and fasting before lunch for the blood draw. Hypoglycemia was asymptomatic and corrected after a normal lunch.
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection (URI)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: In 7-year old after pizza and slushee consumption after playing youth league basketball, and in a 6-year old after a car ride.
Frequency: 1 affected / 5 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Both cases occurred 6-weeks after the infusion, after several days of a URI and fasting before lunch for the blood draw. Hypoglycemia was asymptomatic and corrected after a normal lunch.
Frequency: 1 affected / 5 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk
Study: NCT02508428

Adverse event: Recurrent Dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 116 at risk

Adverse event: Open reduction of dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Wear/Osteolysis without fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reopeartions for polyethylene wear and/or osteolysis without fracture of the bones around the hip joint
Frequency: 10 affected / 114 at risk

Adverse event: Recurrent Dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Wear/Osteolysis with Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractures included the greater trochanter, lesser trochanter and pubic ramus.
Frequency: 7 affected / 114 at risk
Study: NCT02508480

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Participant death due to existing medical conditions.
Frequency: 1 affected / 95 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Participant death due to existing medical conditions.
Frequency: 2 affected / 97 at risk