TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03044574

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Major bleeding defined by the International Society of Thrombosis and Hemostasis (ISTH) (no enough space to provide full definition from Journal of Thrombosis and Haemostasis, 8: 202-204)
Frequency: 5 affected / 204 at risk

Adverse event: Skin hyperemia on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Irritation of the skin on lower limbs in the zone of application of GCS and SCD
Frequency: 18 affected / 204 at risk

Adverse event: Skin blisters on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Deeper skin injury with the formation of blisters in the zone of application of GCS and SCD
Frequency: 3 affected / 204 at risk

Adverse event: Skin necrosis on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Deep lesion of the skin and soft tissues in the zone of application of GCS and SCD
Frequency: 4 affected / 204 at risk

Adverse event: Clinical relevant non-major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bleeding, that does not match the criteria of major but needs some specific measures for hemostasis and/or interruption or preliminary abortion of anticoagulation
Frequency: 2 affected / 204 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Major bleeding defined by the International Society of Thrombosis and Hemostasis (ISTH) (no enough space to provide full definition from Journal of Thrombosis and Haemostasis, 8: 202-204)
Frequency: 4 affected / 203 at risk

Adverse event: Skin hyperemia on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Irritation of the skin on lower limbs in the zone of application of GCS and SCD
Frequency: 13 affected / 203 at risk

Adverse event: Skin blisters on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Deeper skin injury with the formation of blisters in the zone of application of GCS and SCD
Frequency: 1 affected / 203 at risk

Adverse event: Skin necrosis on lower limbs
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Deep lesion of the skin and soft tissues in the zone of application of GCS and SCD
Frequency: 1 affected / 203 at risk

Adverse event: Clinical relevant non-major bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bleeding, that does not match the criteria of major but needs some specific measures for hemostasis and/or interruption or preliminary abortion of anticoagulation
Frequency: 7 affected / 203 at risk
Study: NCT03045068

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 21 at risk

Adverse event: Cardiopulmonary Resuscitation (CPR) Event
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 21 at risk
Study: NCT03045302

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk
Study: NCT03045653

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk
Study: NCT03045809

Adverse event: Allergic reaction to metronidazole
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Allergic reaction to metronidazole; also included nausea, vomiting.
Frequency: 2 affected / 705 at risk
Study: NCT03045861

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Medical device site dermatitis
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 / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Head discomfort
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT03046251

Adverse event: MS relapse
Serious: no
Organ System: Nervous system disorders
Notes: MS relapse not requiring hospitalization
Frequency: 2 affected / 4 at risk

Adverse event: MS relapse
Serious: no
Organ System: Nervous system disorders
Notes: MS relapse not requiring hospitalization
Frequency: 7 affected / 26 at risk
Study: NCT03046446

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 208 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 208 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 208 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 208 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 208 at risk

Adverse event: Joint noise
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 208 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 208 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 208 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 208 at risk
Study: NCT03046836

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nosebleed
Frequency: 1 affected / 100 at risk

Adverse event: Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1- car accident

1 - finger laceration
Frequency: 1 affected / 100 at risk

Adverse event: Cholecystectomy
Serious: no
Organ System: Surgical and medical procedures
Notes: planned procedure
Frequency: 1 affected / 100 at risk
Study: NCT03046927

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 18 at risk

Adverse event: mild hypoglycemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 18 at risk

Adverse event: moderate hypoglycemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: mild hair loss
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: mild hypoglycemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 18 at risk
Study: NCT03047005

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 10 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 34 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 34 at risk
Study: NCT03047031

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk
Study: NCT03047135

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 51 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 51 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 51 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 51 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Lower Extremity
Frequency: 5 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 51 at risk

Adverse event: Pain-Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Alanine Aminotransferase-Increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Aspartate Aminotransferase-increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk
Study: NCT03047330

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Gastrointestional disturbance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 41 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Skin discomfort/irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 41 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 41 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 41 at risk

Adverse event: Menstrual
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 41 at risk

Adverse event: Vasomotor symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 25 affected / 41 at risk

Adverse event: IV discomfort/irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk
Study: NCT03047980

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Subject had a bad migraine with visual aura and was hospitalized on 9/27/2017. He was treated in the ER and hospitalized. Subject has a history of these events prior to going on study drug. This was deemed probably not related to the study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Subject developed a headache with vomiting and tingling/numbness on the left side. She experienced 2 brief focal seizures while in ER. This was probably not related to the study drug as the patient has a history of this event prior to study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject's final visit labs showed asymptomatic anemia with hemoglobin of 7.3. Patient had dark stools previously, making a GI bleed the likely source. She was off the study drug for 2 weeks prior so this is probably not related to the study drug.
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin Ulceration in Mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Increased Alanine Aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Increased aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

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

Adverse event: Decreased HDL Cholesterol
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Abnormal Urine Labs
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Personality change
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 10 at risk

Adverse event: Behavioral Issues/ Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk
Study: NCT03048019

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Notes: Type 2 BARC Bleeding
Frequency: 1 affected / 5 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT03049111

Adverse event: Symptomatic bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: shortness of breath or chest tightness occurring during allergen challenge or within 10 hours post-challenge
Frequency: 2 affected / 14 at risk

Adverse event: Increased asthma symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Increase in symptoms from baseline \>10 hours post-allergen challenge; symptoms include shortness of breath, chest tightness, wheezing or cough. Individual asthma symptoms were not documented and as such cannot be presented separately.
Frequency: 3 affected / 14 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported strained muscle in neck 10 days after allergen challenge
Frequency: 1 affected / 14 at risk
Study: NCT03049280

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Left middle cerebral artery (MCA) stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospital-acquired
Frequency: 1 affected / 33 at risk

Adverse event: clostridium difficile enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Neck seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasal regurgitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 33 at risk

Adverse event: Trismus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk