TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01092195

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 23 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 21 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk
Study: NCT01092338

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Cough/Cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 22 at risk
Study: NCT01092364

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 122 at risk

Adverse event: Musculoskeletal injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 122 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 120 at risk

Adverse event: Musculoskeletal injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 120 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 123 at risk

Adverse event: Obstetric hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 123 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Musculoskeletal injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 123 at risk
Study: NCT01092442

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 68 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk

Adverse event: Explant
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 72 at risk

Adverse event: Reoperation/Reintervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 72 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 72 at risk
Study: NCT01092663

Adverse event: Tingling sensation in lower extremities
Serious: no
Organ System: Nervous system disorders
Notes: Subject complained of tingling sensation in lower extremities accompanied by headache and dry mouth.
Frequency: 1 affected / 31 at risk

Adverse event: Non-related Adverse Event
Serious: no
Organ System: General disorders
Notes: Subject withdrawn due to a non-related adverse event
Frequency: 1 affected / 30 at risk
Study: NCT01092676

Adverse event: nausea and abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: nausea and abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk
Study: NCT01092702

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Depression/Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 32 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk
Study: NCT01092767

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Femoral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk
Study: NCT01092910

Adverse event: Limited benefit
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 57 at risk

Adverse event: Incision Breakdown
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Pain and Facial Weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Chorda Tympani/Taste Disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 57 at risk

Adverse event: Ear effusion/fluid
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 57 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 57 at risk

Adverse event: Dizziness/vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 57 at risk

Adverse event: Incision discomfort/breakdown
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 57 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 57 at risk

Adverse event: Facial weakness/paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Headache/Pain (post-op)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Ear cracking/roaring
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 57 at risk

Adverse event: Otitis externa/TM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 57 at risk
Study: NCT01093183

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: low white blood cell count
Frequency: 2 affected / 25 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: low neutrophil cell count
Frequency: 2 affected / 25 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: low platelet cell counts
Frequency: 1 affected / 25 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: a blood pressure that is below the normal expected for an individual
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: a reduction in the amount of hemoglobin in 100 ml of blood.
Frequency: 1 affected / 25 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: an ANC \<1000/mm3 and a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than one hour.
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: laboratory test results that indicate a low concentration of potassium in the blood
Frequency: 2 affected / 25 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: low white blood cell counts
Frequency: 4 affected / 25 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: laboratory test results that indicate a low concentration of phosphates in the blood
Frequency: 2 affected / 25 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen
Frequency: 2 affected / 25 at risk
Study: NCT01093469

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Worsening ATD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01093534

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 186 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 186 at risk

Adverse event: Pancreatitis necrotising
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Endotoxic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 182 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 182 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 182 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 182 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 175 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 175 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 175 at risk
Study: NCT01093586

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Death not associated with CTCAE term - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bone marrow cellularity - Primary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Product Issues
Notes: Catheter related
Frequency: 2 affected / 14 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT01093651

Adverse event: Hypoglycemia symptoms
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 5 affected / 10 at risk

Adverse event: Upper respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 6 affected / 10 at risk

Adverse event: Generalized fatigue
Serious: no
Organ System: General disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 3 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 4 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 2 affected / 10 at risk

Adverse event: Hypoglycemia symptoms
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 2 affected / 10 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 2 affected / 10 at risk

Adverse event: Upper respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 3 affected / 10 at risk

Adverse event: Generalized fatigue
Serious: no
Organ System: General disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 2 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 1 affected / 10 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Notes: Not SAE; severity graded less than 2 on DAIDS
Frequency: 2 affected / 10 at risk
Study: NCT01093690

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 83 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 39 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 83 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 46 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 79 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 7 affected / 79 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk
Study: NCT01093794

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Leucocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Laboratory finding
Frequency: 1 affected / 28 at risk
Study: NCT01093976

Adverse event: Light-headed / dizziness
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 14 at risk