TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00988325

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

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

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Rotavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

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

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

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

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk
Study: NCT00988351

Adverse event: PAP treatment intolerance
Serious: no
Organ System: General disorders
Notes: unable to use PAP
Frequency: 19 affected / 78 at risk

Adverse event: PAP treatment intolerance
Serious: no
Organ System: General disorders
Notes: unable to use PAP
Frequency: 12 affected / 78 at risk
Study: NCT00988533

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk
Study: NCT00988559

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Notes: Local injection site reactions
Frequency: 8 affected / 10 at risk

Adverse event: General pain, fever, malaise/fatigue
Serious: no
Organ System: General disorders
Notes: Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus
Frequency: 8 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Notes: Local injection site reactions
Frequency: 6 affected / 11 at risk

Adverse event: General pain, fever, malaise/fatigue
Serious: no
Organ System: General disorders
Notes: Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus
Frequency: 8 affected / 11 at risk

Adverse event: Limb numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Notes: Local injection site reactions
Frequency: 1 affected / 11 at risk

Adverse event: General pain, fever, malaise/fatigue
Serious: no
Organ System: General disorders
Notes: Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus
Frequency: 8 affected / 11 at risk

Adverse event: Vaginal bleeding/spotting
Serious: no
Organ System: Reproductive system and breast disorders
Notes: vaginal bleeding or spotting
Frequency: 3 affected / 11 at risk

Adverse event: General pain, fever, malaise/fatigue
Serious: no
Organ System: General disorders
Notes: Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus
Frequency: 7 affected / 7 at risk

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

Adverse event: Rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Vaginal bleeding/spotting
Serious: no
Organ System: Reproductive system and breast disorders
Notes: vaginal bleeding or spotting
Frequency: 1 affected / 7 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT00988598

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk
Study: NCT00988637

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
Frequency: 4 affected / 70 at risk
Study: NCT00988884

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 613 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 613 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 613 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 613 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 245 affected / 613 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 518 affected / 613 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 276 affected / 613 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 88 affected / 613 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 613 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 140 affected / 613 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 613 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 611 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 611 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 611 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 611 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 611 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 611 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 233 affected / 611 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 490 affected / 611 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 255 affected / 611 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 95 affected / 611 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 611 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 611 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 611 at risk
Study: NCT00989014

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk
Study: NCT00989157

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Emesis post drug ingestion
Frequency: 2 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Emesis post drug ingestion
Frequency: 3 affected / 10 at risk
Study: NCT00989196

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk
Study: NCT00989586

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 35 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: due to disease progression within 30 days of treatment
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 35 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 35 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 35 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 35 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 35 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 35 at risk

Adverse event: Infusion Reactions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk
Study: NCT00989612

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pharyngeal ulceration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
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: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 100 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 37 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 100 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 69 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 100 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 99 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 100 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 100 at risk
Study: NCT00989768

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk
Study: NCT00989833

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 21 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 23 at risk
Study: NCT00989911

Adverse event: Fatigue
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 10 at risk
Study: NCT00989950

Adverse event: skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 9 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 7 at risk
Study: NCT00990093

Adverse event: discomfort during insertion
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk
Study: NCT00990106

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 32 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 32 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant hospitalized for suicidal ideation.
Frequency: 1 affected / 35 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant took a nonlethal overdose of oxycodone/acetaminophen as a suicide attempt.
Frequency: 1 affected / 35 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: lack of energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Frequency: 25 affected / 35 at risk
Study: NCT00990184

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk
Study: NCT00990236

Adverse event: Superficial venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 89 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Superficial venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 96 at risk