TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02267317

Adverse event: Phlebitis Grade 1, 2 or 3
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 11 at risk

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

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

Adverse event: Phlebitis Grade 1, 2 or 3
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 11 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Phlebitis Grade 1, 2 or 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Phlebitis Grade 1, 2 or 3
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3 at risk
Study: NCT02267538

Adverse event: Intraoperative Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \< 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes
Frequency: 21 affected / 142 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Vascular disorders
Notes: a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes
Frequency: 10 affected / 142 at risk

Adverse event: Postoperative Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \< 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes
Frequency: 2 affected / 142 at risk

Adverse event: Post procedural hypotension
Serious: no
Organ System: Vascular disorders
Notes: a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes
Frequency: 5 affected / 142 at risk

Adverse event: Intraoperative Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \< 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes
Frequency: 14 affected / 143 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Vascular disorders
Notes: a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes
Frequency: 10 affected / 143 at risk

Adverse event: Postoperative Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \< 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes
Frequency: 6 affected / 143 at risk

Adverse event: Post procedural hypotension
Serious: no
Organ System: Vascular disorders
Notes: a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes
Frequency: 10 affected / 143 at risk
Study: NCT02267577

Adverse event: High Blood Pressure
Serious: yes
Organ System: Cardiac disorders
Notes: One healthy volunteer presented with abnormally high blood pressure. EMS was called and the subject was evaluated. Following the evaluation, the subject was advised to visit their primary care physician regarding their high blood pressure.
Frequency: 1 affected / 85 at risk
Study: NCT02267772

Adverse event: Adverse reaction to demerol administered as rescue medication, which required narcan for reversal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 43 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 43 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 17 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 51 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 15 affected / 51 at risk
Study: NCT02267824

Adverse event: Cheek redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 83 at risk
Study: NCT02268084

Adverse event: Headache (Mild)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache (Mild)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk
Study: NCT02268305

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk
Study: NCT02268396

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chronic Obstructive pulmonary disease
Frequency: 2 affected / 138 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 138 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 138 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chronic Obstructive Pulmonary disease
Frequency: 10 affected / 138 at risk
Study: NCT02268474

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 22 at risk
Study: NCT02268656

Adverse event: Bradycardia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT02268864

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 106 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 106 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 106 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk
Study: NCT02268877

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 118 at risk

Adverse event: intrauterine fetal demise
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 118 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 106 at risk

Adverse event: intrauterine fetal demise
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 106 at risk
Study: NCT02268916

Adverse event: Minor , possibly study related adverse events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle sprain, knee pain
Frequency: 2 affected / 52 at risk

Adverse event: Minor, possibly related to the study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: toe nail bleed may be related to walking
Frequency: 1 affected / 52 at risk

Adverse event: Minor, possibly study related adverse events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A fall under unclear circumstances and did not need to seek medical care
Frequency: 1 affected / 52 at risk
Study: NCT02268942

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 144 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 57 affected / 144 at risk

Adverse event: Device Malfunction/Failure and/or Pump Thrombus
Serious: yes
Organ System: Product Issues
Frequency: 42 affected / 144 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 144 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 66 affected / 144 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Vascular disorders
Frequency: 38 affected / 144 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 53 affected / 144 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 144 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 144 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 144 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 144 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 144 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 144 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 144 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: "Other" is an adverse event term category in the Intermacs registry and no additional data was provided.
Frequency: 44 affected / 144 at risk
Study: NCT02269098

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: arthritis pain exacerbation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: hospitalization due to exacerbation of gastroperisis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient with history of poorly controlled diabetes and of gastroperisis related emergency room visits and hospitlalizations
Frequency: 1 affected / 50 at risk

Adverse event: hyperglycemia requiring return to Emergency room
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: arthritis pain exacerbation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk
Study: NCT02269319

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Moderate SAE unrelated to study drug
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk
Study: NCT02269488

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 100 at risk
Study: NCT02269670

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT02269787

Adverse event: Incapacitation
Serious: yes
Organ System: General disorders
Notes: Too incapacitated by poor health to complete follow-up assessment.
Frequency: 1 affected / 150 at risk
Study: NCT02270242

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 95 affected / 3524 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 3524 at risk

Adverse event: Stent Thrombosis, definite or probable
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 3524 at risk

Adverse event: BARC 235
Serious: yes
Organ System: Vascular disorders
Notes: BARC type 2, 3, 5 bleeding
Frequency: 141 affected / 3555 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 97 affected / 3515 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 3515 at risk

Adverse event: Stent Thrombosis, definite or probable
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 3515 at risk

Adverse event: BARC 235
Serious: yes
Organ System: Vascular disorders
Notes: BARC type 2, 3, 5 bleeding
Frequency: 250 affected / 3564 at risk
Study: NCT02270255

Adverse event: Pain during the block procedure itself
Serious: no
Organ System: Nervous system disorders
Notes: Temporary discomfort/pain during placement of the block needle.
Frequency: 6 affected / 22 at risk

Adverse event: Hard fibroid needing use of 18g needle
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tachycardia, transient, from Xylocaine with epi injection
Serious: no
Organ System: Cardiac disorders
Notes: To ensure no intravascular injection of long-acting block agent, a test dose of Xylocaine with epi is injected. One patient had a transient tachycardia confirming intravascular uptake and needing change in needle position.
Frequency: 1 affected / 22 at risk

Adverse event: Aspiration of blood
Serious: no
Organ System: Vascular disorders
Notes: Aspiration of blood prior to injecting anesthetic, needing needle repositioning.
Frequency: 1 affected / 22 at risk

Adverse event: Temporary heat sensation in foot
Serious: no
Organ System: Nervous system disorders
Notes: Presumably from sympathetic chain blockade
Frequency: 1 affected / 22 at risk

Adverse event: Temporary heaviness in foot
Serious: no
Organ System: Nervous system disorders
Notes: Resolved by the end of the time in the PACU
Frequency: 1 affected / 22 at risk
Study: NCT02270645

Adverse event: Fibrosing on histology result
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02270983

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 78 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 87 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 87 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk
Study: NCT02271425

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk
Study: NCT02271529

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vascular injury requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Extensive metastatic disease of the abdomen and pelvis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ooze from left groin access site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk
Study: NCT02271698

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: wound dehisence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: urine retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

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

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

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

Adverse event: urine retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk