TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01262677

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 100 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 100 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 113 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 113 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 113 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 113 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 113 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 110 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk
Study: NCT01262846

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 95 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local at injection site
Frequency: 4 affected / 95 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local at injection site
Frequency: 1 affected / 95 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 1 affected / 95 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 10 affected / 95 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 95 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 95 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 95 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 14 affected / 95 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 95 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local at injection site
Frequency: 15 affected / 100 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local at injection site
Frequency: 3 affected / 100 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 2 affected / 100 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local
Frequency: 10 affected / 100 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk
Study: NCT01262989

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Extremities burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

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

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Serum glutamic-pyruvic increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Gamma glutamyl transferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Serum glutamic-oxaloacetic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01263028

Adverse event: Low Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk
Study: NCT01263132

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Lower Limb Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Viral Rhinopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk

Adverse event: Lower Limb Edema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Acute Otitis Media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Widespread Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk
Study: NCT01263379

Adverse event: Neoplasms benign, malignant and unspecified, squamous cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: PAIN OF WOUND SITES
Frequency: 2 affected / 7 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound drainage
Frequency: 1 affected / 7 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 7 at risk
Study: NCT01263444

Adverse event: Pseudo stenocardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk
Study: NCT01263483

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 76 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 79 at risk
Study: NCT01263769

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 24 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 24 at risk

Adverse event: Oral mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 24 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 24 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: AST/ALT increase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 24 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Myalgias
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Scrotal skin rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk
Study: NCT01264016

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Since the subjects were people with diabetes, these hypoglycemia adverse events were anticipated and not related to the device. Also, all adverse events were mild.
Frequency: 13 affected / 96 at risk
Study: NCT01264081

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Pulmonary embolus
Frequency: 1 affected / 3 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death due to progressive disease
Frequency: 2 affected / 3 at risk

Adverse event: Rash maculo-paular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: Psychiatric disorders
Frequency: 1 affected / 3 at risk
Study: NCT01264601

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A 3 yr old with milk and egg allergy developed anaphylaxis within few min. of consuming a chocolate sauce labeled as having both milk and egg, app. 24 hours after vaccine. Per the PIs at Univ. of Mich., this event believed unrelated to the study.
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 year old boy vomited app. 28 min. post-vaccination after vigorously running around. Was otherwise playful and no other symptoms of IgE-mediated reactivity. Per the PIs at Univ. of Michigan, this event was believed to be unrelated to the study.
Frequency: 1 affected / 14 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: 12 yr old boy, receiving first TIV, reported Tachycardia 24 hours after vaccincation but no symptoms noted during observation period or later on same day/night. Per the PIs at the Univ. of Michigan, event believed to be unrelated to the study.
Frequency: 1 affected / 14 at risk
Study: NCT01264705

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 41 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 41 at risk

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

Adverse event: Hand /foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

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

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: stomstitis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: hiccoughs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk
Study: NCT01264835

Adverse event: Rectal Ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01264952

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal abcess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Transient liver failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Small bowl obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal abcess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 8 at risk

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

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Transient liver failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Jaundice cholestatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Biliary fistula
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 8 at risk
Study: NCT01264965

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 25 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk
Study: NCT01265394

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 181 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 12 affected / 181 at risk

Adverse event: Vascular System Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 181 at risk

Adverse event: Vascular System Disorders-Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 181 at risk
Study: NCT01265420

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

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

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

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

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

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