TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00327717

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 120 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 120 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 120 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 120 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 120 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 120 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 120 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 118 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 118 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 118 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 118 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 118 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 118 at risk

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 118 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 118 at risk
Study: NCT00328094

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Blood glucose \< 60 mg/dL atleast once
Frequency: 10 affected / 114 at risk

Adverse event: Creatinine > 25% increase
Serious: no
Organ System: Renal and urinary disorders
Notes: INcrease in creatinine \> 25% in the postoperative period from the preoperative period
Frequency: 23 affected / 114 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Blood glucose \< 60 mg/dL atleast once
Frequency: 5 affected / 122 at risk

Adverse event: Creatinine > 25% increase
Serious: no
Organ System: Renal and urinary disorders
Notes: INcrease in creatinine \> 25% in the postoperative period from the preoperative period
Frequency: 22 affected / 122 at risk
Study: NCT00328263

Adverse event: Serious Adverse Events
Serious: yes
Organ System: General disorders
Notes: None of the serious adverse events were related to the treatment product.
Frequency: 15 affected / 216 at risk

Adverse event: Gastrointestinal adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: The most frequently reported non serious adverse events were constipation, flatulence and nausea.
Frequency: 35 affected / 216 at risk

Adverse event: Other adverse events
Serious: no
Organ System: Nervous system disorders
Notes: Vulvovaginal mycotic infection, muscle spasms, hyperthermia, pyrexia, arthralgia, headache, dyspnea, presence of at least one treatment-emergent non serious adverse event
Frequency: 74 affected / 216 at risk

Adverse event: Serious Adverse Events
Serious: yes
Organ System: General disorders
Notes: None of the serious adverse events were related to the treatment product.
Frequency: 23 affected / 221 at risk

Adverse event: Gastrointestinal adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: The most frequently reported non serious adverse events were constipation, flatulence and nausea.
Frequency: 30 affected / 221 at risk

Adverse event: Other adverse events
Serious: no
Organ System: Nervous system disorders
Notes: Vulvovaginal mycotic infection, muscle spasms, hyperthermia, pyrexia, arthralgia, headache, dyspnea, presence of at least one treatment-emergent non serious adverse event
Frequency: 83 affected / 221 at risk
Study: NCT00328562

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 12 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Decreased whole blood count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Side pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bladder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Salivary gland changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk
Study: NCT00328614

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain and cramping
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Blood/bone marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 6 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Blood/bone marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 6 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 6 at risk

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

Adverse event: Libido decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urine color changed
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Hot flashes/flushes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT00328770

Adverse event: Hematological toxicity
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia defined as hemoglobin under 8 g/dL for at least one week or requiring treatment. Leucopenia defined as leukocyte counts under 3 x 10-9/L for at least 5 days or requiring granulocyte colony-stimulating factor therapy.
Frequency: 4 affected / 70 at risk

Adverse event: Delayed wound healing
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Delayed wound healing defined as a wound still requiring nursing therapy one month after surgery.
Frequency: 3 affected / 70 at risk

Adverse event: Mouth ulcers
Serious: no
Organ System: Gastrointestinal disorders
Notes: Oral ulcers necessitating patients being discontinued from sirolimus therapy
Frequency: 2 affected / 70 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dyslipidemia necessitating patient have sirolimus discontinued.
Frequency: 1 affected / 70 at risk

Adverse event: Other unspecified reasons for discontinuation of sirolimus
Serious: no
Organ System: General disorders
Notes: Reasons patients were discontinued from sirolimus therapy were not specified by the physicians who took the patients off the medication.
Frequency: 3 affected / 70 at risk
Study: NCT00329030

Adverse event: Acute graft versus host disease in liver
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 111 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 111 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 111 at risk

Adverse event: Orchidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 111 at risk

Adverse event: Engraft failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 111 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Eosinophilic oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 113 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 113 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 113 at risk
Study: NCT00329303

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 34 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 34 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 37 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk
Study: NCT00329407

Adverse event: Agitation and Impaired Concentration
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk
Study: NCT00329745

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4359 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4359 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4359 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4359 at risk

Adverse event: Burns third degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4359 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4359 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4359 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4359 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4328 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4328 at risk

Adverse event: Upper respiratory tract
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4328 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4328 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4328 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4328 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4328 at risk

Adverse event: Dehydratation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4328 at risk

Adverse event: Epyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4328 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4328 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4328 at risk
Study: NCT00329849

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 950 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 950 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 950 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 950 at risk

Adverse event: Tonic convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 950 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 950 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 221 affected / 950 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 166 affected / 950 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 125 affected / 950 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 143 affected / 950 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 75 affected / 950 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 50 affected / 950 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 550 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 168 affected / 550 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 71 affected / 550 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 550 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 61 affected / 550 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 49 affected / 550 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 28 affected / 550 at risk
Study: NCT00330174

Adverse event: Clinical Deterioration
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant in the placebo group experienced suicidal ideation and was hospitalized; one participant in the acamprosate group had worsening of alcohol use and was put in a higher level of care
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Clinical Deterioration
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant in the placebo group experienced suicidal ideation and was hospitalized; one participant in the acamprosate group had worsening of alcohol use and was put in a higher level of care
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 45 at risk
Study: NCT00330187

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 37 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 37 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 37 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 36 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 29 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 29 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 29 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

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

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk
Study: NCT00330343

Adverse event: Nausea, Vomiting or pruritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, or pruritis
Frequency: 32 affected / 59 at risk