TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01173848

Adverse event: Left Side Back Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hospitalization for Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nails Cracking and Falling Off
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Cystic fibrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Worsening Hyperglycemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urine abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haematuria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Stomach Cramping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: High Potassium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Allergies
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk
Study: NCT01173874

Adverse event: Exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 56 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk
Study: NCT01174082

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

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

Adverse event: Abd cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk
Study: NCT01174173

Adverse event: Inpatient hospitalization
Serious: yes
Organ System: Nervous system disorders
Notes: 1 patient reported symptoms of dizziness, leg weakness, and hand tremors; Because of possibility of an interaction between ranolazine and darifenacin, ranolazine was discontinued, patient withdrawn from the study, and had complete resolution.
Frequency: 1 affected / 11 at risk

Adverse event: Myalgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk
Study: NCT01174186

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient admitted with abdominal pains after consuming alcohol. Was discharged the next day after lab results came out normal and abdominal pains had subsided
Frequency: 1 affected / 15 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Admitted to hospital because of severe anemia. Patient was bleeding from a Meckel's diverticulum
Frequency: 1 affected / 15 at risk
Study: NCT01174368

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Micturition urgency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT01174446

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Traumatic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Hepatitis B core antibody positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 73 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 73 at risk

Adverse event: Immunology test abnormal
Serious: no
Organ System: Investigations
Frequency: 12 affected / 73 at risk
Study: NCT01174459

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 510 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 510 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 510 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 510 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 510 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 510 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 510 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 510 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 510 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 510 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 510 at risk

Adverse event: Impulse-control disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 510 at risk

Adverse event: Somatic hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 510 at risk
Study: NCT01174550

Adverse event: Death- Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 5007 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 5007 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 5007 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 5007 at risk

Adverse event: Unstable Angina Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 5007 at risk

Adverse event: Death - Non cardiovascular known cause
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 5007 at risk

Adverse event: Death - unknown cause
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 5007 at risk

Adverse event: Exercise Induced Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 5007 at risk

Adverse event: Stress Induced Symptoms Related to Functional Testing
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 5007 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 5007 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 5007 at risk

Adverse event: Hospital Admission Not In The Primary Endpoint
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5007 at risk

Adverse event: Any Event Potentially Related to Vasodilators
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 5007 at risk

Adverse event: Death- Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 4996 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4996 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 4996 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4996 at risk

Adverse event: Unstable Angina Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 61 affected / 4996 at risk

Adverse event: Death - Non cardiovascular known cause
Serious: yes
Organ System: General disorders
Frequency: 33 affected / 4996 at risk

Adverse event: Death - unknown cause
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 4996 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 4996 at risk

Adverse event: Mild Contrast Reaction (rash or hives)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 4996 at risk

Adverse event: Extravasion of Contrast Into Surrounding Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 4996 at risk
Study: NCT01174784

Adverse event: Clinically Significant Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 84 at risk
Study: NCT01174823

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Mild taste following instillation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Mild taste following instillation
Serious: no
Organ System: General disorders
Frequency: 10 affected / 123 at risk
Study: NCT01175018

Adverse event: New onset heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Serious infection
Serious: yes
Organ System: Infections and infestations
Notes: requiring or prolonging hospital admission, or requiring intravenous antibiotics
Frequency: 2 affected / 15 at risk

Adverse event: Recurrent myocardial infarction or repeat percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bleeding (not serious)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Infection (not serious)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: New onset heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 15 at risk

Adverse event: Serious infection
Serious: yes
Organ System: Infections and infestations
Notes: requiring or prolonging hospital admission, or requiring intravenous antibiotics
Frequency: 2 affected / 15 at risk

Adverse event: Recurrent myocardial infarction or repeat percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Left ventricular thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Myocardial rupture
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac rupture
Frequency: 1 affected / 15 at risk

Adverse event: Bleeding (not serious)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk
Study: NCT01175148

Adverse event: Myalgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Liver function test
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT01175226

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 154 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 154 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 154 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 145 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 145 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 145 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 145 at risk
Study: NCT01175382

Adverse event: Admittance to Hospital for Suicidal Thoughts
Serious: yes
Organ System: Psychiatric disorders
Notes: Deemed unrelated to Behavioral Intervention
Frequency: 1 affected / 71 at risk

Adverse event: Taking too much study medication
Serious: yes
Organ System: General disorders
Notes: Subject within the Drug Only group misunderstood dosing regimen. No side effects observed, but reported to Internal Review Board (IRB) as Adverse Event
Frequency: 1 affected / 68 at risk

Adverse event: Admitted to Hospital for Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: Subject within Drug Arm had a prior valve replacement 12 years prior to the study. Upon hospitalization, cardiology deemed a new valve was needed. It was deemed by the Data Safety Monitoring Board (DSMB), the Adverse Event was not related to study.
Frequency: 1 affected / 68 at risk

Adverse event: Admission to Hospital for Shortness of Breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient within the Combined Arm was admitted to hospital for observation due to shortness of breath. Patient was discharged, expressed desire to continue in the study. DSMB concluded adverse event was not associated with study or study drug.
Frequency: 1 affected / 65 at risk
Study: NCT01175395

Adverse event: fracture of sacrum
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 10 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 10 at risk

Adverse event: cataract surgery
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: temporal pallor of optic nerve
Serious: no
Organ System: Eye disorders
Notes: Secondary and due to retinal atrophy.
Frequency: 1 affected / 10 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: infective vaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated to eye condition or treatment.
Frequency: 1 affected / 10 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: watery eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk
Study: NCT01175473

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 77 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 77 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 77 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 77 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 71 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 71 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 71 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 71 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 71 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 71 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 71 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 71 at risk
Study: NCT01175668

Adverse event: Sedation complication
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk