TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02371187

Adverse event: Headaches and Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: General Stomach Pain and Diarrhea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Muscle soreness and joint pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 18 at risk

Adverse event: Urinary Disorders and Yeast Infections
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash or skin irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headaches and Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 19 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 10 affected / 19 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: General Stomach Pain and Diarrhea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Muscle soreness and joint pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 19 at risk

Adverse event: Urinary Disorders and Yeast Infections
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

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

Adverse event: Rash or skin irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT02371252

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 70 at risk

Adverse event: myalgia and arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 70 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: myalgia and arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 70 at risk
Study: NCT02371850

Adverse event: Erythema at the site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated Respiratory Rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: pruritus at patch application site
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Miliaria
Serious: no
Organ System: General disorders
Notes: due to heating pad application
Frequency: 1 affected / 10 at risk

Adverse event: Elevated systolic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Erythema at the site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Elevated Respiratory Rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Skin redness
Serious: no
Organ System: General disorders
Notes: TDS site (due to external heat application)
Frequency: 1 affected / 10 at risk

Adverse event: Erythema at the site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated Respiratory Rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated systolic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Erythema at the site of patch placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated Respiratory Rate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Notes: (transient) right thumb
Frequency: 1 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk
Study: NCT02371876

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects' hypoglycemia were resolved at the visit.
Frequency: 4 affected / 134 at risk
Study: NCT02371889

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 21 affected / 85 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 85 at risk

Adverse event: Pain and discomfort
Serious: no
Organ System: General disorders
Frequency: 16 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 85 at risk

Adverse event: Upper respiratory infections
Serious: no
Organ System: General disorders
Frequency: 21 affected / 85 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: General disorders
Frequency: 17 affected / 85 at risk

Adverse event: Speech/Language abnormalities
Serious: no
Organ System: General disorders
Frequency: 18 affected / 85 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: General disorders
Frequency: 9 affected / 85 at risk

Adverse event: alcohol-related relapse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 85 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 85 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 85 at risk

Adverse event: Pain and discomfort
Serious: no
Organ System: General disorders
Frequency: 17 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 85 at risk

Adverse event: Upper respiratory infections
Serious: no
Organ System: General disorders
Frequency: 10 affected / 85 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: General disorders
Frequency: 7 affected / 85 at risk

Adverse event: Speech/Language abnormalities
Serious: no
Organ System: General disorders
Frequency: 3 affected / 85 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 6 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 85 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk
Study: NCT02371941

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk
Study: NCT02372136

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrotizing enterocolitis stage II or greater (modified Bell's classification)
Frequency: 6 affected / 62 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Notes: Feeding intolerance (feeds held for 24 h for abdominal distention, vomiting or residuals)
Frequency: 19 affected / 62 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrotizing enterocolitis stage II or greater (modified Bell's classification)
Frequency: 5 affected / 58 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Gastrointestinal disorders
Notes: Feeding intolerance (feeds held for 24 h for abdominal distention, vomiting or residuals)
Frequency: 17 affected / 58 at risk
Study: NCT02372253

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

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk
Study: NCT02372344

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 42 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk
Study: NCT02372409

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

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

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

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

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

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Noise sensitive
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 5 at risk
Study: NCT02373098

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 66 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 66 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk
Study: NCT02373137

Adverse event: Glaucoma (nonsurgical)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Glaucoma (surgical)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

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

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

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

Adverse event: Visually significant central epithelial opacity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Postoperative day 1 pupillary block
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Glaucoma (nonsurgical)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Glaucoma (surgical)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

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

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

Adverse event: Re-bubble
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 25 at risk

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

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

Adverse event: Epiretinal membrane and lamellar hole
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk
Study: NCT02373371

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT02373852

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiogenic shock
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain on effort
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 12 at risk
Study: NCT02374021

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 79 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Neoplasms Benign Malignant And Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 79 at risk
Study: NCT02374060

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 65 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

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

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

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

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 63 at risk

Adverse event: Mediastinoscopy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Choroidal
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Shoulder arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 64 at risk
Study: NCT02374164

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk
Study: NCT02374307

Adverse event: Musculoskeletal pain/discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal pain/discomfort after using ankle cuffs
Frequency: 3 affected / 77 at risk
Study: NCT02374463

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: surgery
Frequency: 1 affected / 15 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: surgery
Frequency: 1 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 12 at risk
Study: NCT02374671

Adverse event: Serious Non-Ocular Adverse Events
Serious: yes
Organ System: General disorders
Notes: Any Serious Non-Ocular Adverse Events
Frequency: 4 affected / 360 at risk

Adverse event: Visual Acuity
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 360 at risk

Adverse event: Lid
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 360 at risk

Adverse event: Cornea/Conjunctiva
Serious: no
Organ System: Eye disorders
Frequency: 89 affected / 360 at risk

Adverse event: Iris/Pupil
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 360 at risk

Adverse event: Anterior Chamber
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 360 at risk

Adverse event: Lens
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 360 at risk

Adverse event: Sclera (Intraoperative Events)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 360 at risk

Adverse event: Intraocular pressure test
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 360 at risk

Adverse event: Fundus/Posterior Pole
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 360 at risk

Adverse event: Secondary Surgical Intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 23 affected / 360 at risk

Adverse event: Allergic Reactions to Medications
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 360 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Frequency: 50 affected / 360 at risk
Study: NCT02374957

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patients went on to have amputations after initial procedure.
Frequency: 1 affected / 10 at risk

Adverse event: Haemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient went on to diaysis
Frequency: 1 affected / 10 at risk

Adverse event: Other non-CVD
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal Mass
Frequency: 1 affected / 10 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patients went on to have amputations after initial procedure.
Frequency: 2 affected / 9 at risk

Adverse event: Haemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient went on to diaysis
Frequency: 1 affected / 9 at risk

Adverse event: Suspected MI
Serious: yes
Organ System: Cardiac disorders
Notes: Patient expired from suspected myocardial infarction
Frequency: 1 affected / 9 at risk
Study: NCT02375113

Adverse event: Discomfort of ingesting daily protein shake
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT02375347

Adverse event: Cracked Tooth
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk