TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00720499

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 139 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 139 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 138 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 138 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 138 at risk
Study: NCT00720629

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hemorrhage, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Infection - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Infection - Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pulmonary/Upper Respiratory - Other - pseudomonas pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT00720759

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT00721136

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pocket Hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk
Study: NCT00721149

Adverse event: Small hematoma - left groin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gallstone, pancreatitis, cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk
Study: NCT00721175

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 54 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 54 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 54 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 54 at risk

Adverse event: sphicterotomy bleeding
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 54 at risk
Study: NCT00721188

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk
Study: NCT00721279

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk
Study: NCT00721357

Adverse event: fall at home
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject reported a fall int he home but did not result in injury
Frequency: 1 affected / 15 at risk
Study: NCT00721578

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk
Study: NCT00721955

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 105 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 104 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 104 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 105 at risk
Study: NCT00721968

Adverse event: IOP increase >=10 mmHg versus baseline IOP at any visit
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 27 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 27 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 27 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Punctate Corneal Staining
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: IOP increase >=10 mmHg versus baseline IOP at any visit
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 17 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Punctate Corneal Staining
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: BCVA Loss greater than or equal to 1 line after 3 months post-op
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk
Study: NCT00722072

Adverse event: Hand-foot syndrome (HFS)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Skin exfoliation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 9 at risk

Adverse event: Myalgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 9 at risk

Adverse event: Arthralgias
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 9 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 9 at risk
Study: NCT00722124

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

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

Adverse event: drowsiness/fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

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

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk
Study: NCT00722423

Adverse event: Hospitalization Events
Serious: yes
Organ System: General disorders
Notes: Subjects with a hospital event
Frequency: 104 affected / 182 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Led to death
Frequency: 1 affected / 182 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Led to death
Frequency: 1 affected / 182 at risk

Adverse event: Medication Overdose
Serious: yes
Organ System: General disorders
Notes: Led to death in IC group
Frequency: 1 affected / 182 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Led to death
Frequency: 2 affected / 182 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 182 at risk

Adverse event: Hospitalization Events
Serious: yes
Organ System: General disorders
Notes: Subjects with a hospital event
Frequency: 112 affected / 181 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Led to death
Frequency: 2 affected / 181 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Led to death
Frequency: 2 affected / 181 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Led to death
Frequency: 2 affected / 181 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 181 at risk
Study: NCT00722722

Adverse event: Anemia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Thrombocytopenia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhea Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anemia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anemia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 5 at risk

Adverse event: Thrombocytopenia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Nausea/Vomiting Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Diarrhea Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhea Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Flu-like symptoms Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Myalgias Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Anemia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Anemia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 10 at risk

Adverse event: Thrombocytopenia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 10 at risk

Adverse event: Thrombocytopenia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leukopenia Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea/Vomiting Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Diarrhea Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

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

Adverse event: Flu-like symptoms Grade 1
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Myalgias Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 10 at risk

Adverse event: Chills Grade 1
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Fatigue Grade 1
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT00722761

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: moodiness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk
Study: NCT00722800

Adverse event: fistula with bacterial infection R-axilla
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT00723008

Adverse event: Ear Pain, Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Increased Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Increased Injury Site Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sleep terror
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 11 at risk

Adverse event: Ear Pain, Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ear Pain, Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Increased Injury Site Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

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

Adverse event: Stiffness/ soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ear Pain, Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Increased Injury Site Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT00723073

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 149 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 149 at risk

Adverse event: AST > 5x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 149 at risk

Adverse event: ALT > 5x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 149 at risk

Adverse event: Total Bilirubin > 3x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 149 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Liver function test elevation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: AST > 5x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 174 at risk

Adverse event: ALT > 5x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 174 at risk

Adverse event: Total Bilirubin > 3x ULN
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 174 at risk
Study: NCT00723177

Adverse event: GI upset and Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 15 at risk

Adverse event: GI upset and Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 14 at risk

Adverse event: GI upset and Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 15 at risk