TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00330421

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Fatigue
Frequency: 11 affected / 15 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin
Frequency: 8 affected / 15 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Elevated alk phos
Frequency: 7 affected / 15 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Elevated AST
Frequency: 7 affected / 15 at risk

Adverse event: Hematologic - other
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Other hematologic issue, including thrombocytopenia and clotting dysfunction
Frequency: 6 affected / 15 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diarrhea without prior colostomy
Frequency: 6 affected / 15 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 5 affected / 15 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: General disorders
Notes: Hand-foot reaction
Frequency: 7 affected / 15 at risk
Study: NCT00330551

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: psychiatric hospitalization
Frequency: 2 affected / 40 at risk

Adverse event: BMI increase from normal or overweight to Obese
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: increase in BMI from normal or overweight to any Obese category
Frequency: 7 affected / 40 at risk

Adverse event: Lipid Increase
Serious: no
Organ System: Vascular disorders
Notes: Increase in LDL or Triglycerides from normal to high
Frequency: 2 affected / 40 at risk

Adverse event: Tardive dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: New onset of mild symptoms of Tardive Dyskinesia
Frequency: 2 affected / 40 at risk

Adverse event: Prolactin related
Serious: no
Organ System: Endocrine disorders
Notes: Symptoms related to prolactin levels
Frequency: 3 affected / 40 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: psychiatric hospitalization
Frequency: 8 affected / 43 at risk

Adverse event: BMI increase from normal or overweight to Obese
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: increase in BMI from normal or overweight to any Obese category
Frequency: 5 affected / 43 at risk

Adverse event: Lipid Increase
Serious: no
Organ System: Vascular disorders
Notes: Increase in LDL or Triglycerides from normal to high
Frequency: 9 affected / 43 at risk

Adverse event: Tardive dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: New onset of mild symptoms of Tardive Dyskinesia
Frequency: 3 affected / 43 at risk

Adverse event: Prolactin related
Serious: no
Organ System: Endocrine disorders
Notes: Symptoms related to prolactin levels
Frequency: 4 affected / 43 at risk
Study: NCT00330564

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: hand foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT00330616

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 35 at risk

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

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

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

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Paraesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

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

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

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

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

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 35 at risk

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

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

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk
Study: NCT00330733

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded \> mild
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded \> mild
Frequency: 4 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 34 at risk
Study: NCT00330863

Adverse event: first relapse often hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 61 affected / 146 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Notes: Anorexia was higher in injectable arm than in oral arm.
Frequency: 143 affected / 143 at risk

Adverse event: first relapse often hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 48 affected / 150 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Notes: Anorexia was higher in injectable arm than in oral arm.
Frequency: 148 affected / 148 at risk
Study: NCT00330928

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 106 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Chest Pain/Shortness of Breath
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 106 at risk
Study: NCT00330967

Adverse event: Oedema
Serious: yes
Organ System: Surgical and medical procedures
Notes: Right lower extremity edema following muscle biopsy.
Frequency: 1 affected / 25 at risk
Study: NCT00331162

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

Adverse event: Renal Allograft Pseudoaneurysm
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 113 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 113 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 113 at risk

Adverse event: Cardiovascular Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 109 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Posttransplant lymphoproliferative disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 109 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 109 at risk

Adverse event: Other (nonskin) Malignancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 109 at risk
Study: NCT00332332

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Thyroid adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 230 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 230 at risk
Study: NCT00332579

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk
Study: NCT00332605

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 17 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT00333177

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: psychiatric hospitalization
Frequency: 1 affected / 12 at risk

Adverse event: BMI increase normal/overweight to Obese
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increase in BMI from normal/overweight to any Obese category
Frequency: 3 affected / 12 at risk

Adverse event: LDL or Triglyceride increase
Serious: no
Organ System: Cardiac disorders
Notes: increase from normal to high in either LDL or Triglyceride
Frequency: 1 affected / 12 at risk

Adverse event: TD early signs
Serious: no
Organ System: Nervous system disorders
Notes: Early signs of mild tardive dyskinesia
Frequency: 1 affected / 12 at risk

Adverse event: Prolactin related symptom
Serious: no
Organ System: Endocrine disorders
Notes: Symptom related to prolactin level
Frequency: 2 affected / 12 at risk

Adverse event: BMI increase normal/overweight to Obese
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increase in BMI from normal/overweight to any Obese category
Frequency: 2 affected / 16 at risk

Adverse event: LDL or Triglyceride increase
Serious: no
Organ System: Cardiac disorders
Notes: increase from normal to high in either LDL or Triglyceride
Frequency: 1 affected / 16 at risk

Adverse event: TD early signs
Serious: no
Organ System: Nervous system disorders
Notes: Early signs of mild tardive dyskinesia
Frequency: 1 affected / 16 at risk

Adverse event: Prolactin related symptom
Serious: no
Organ System: Endocrine disorders
Notes: Symptom related to prolactin level
Frequency: 1 affected / 16 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: psychiatric hospitalization
Frequency: 3 affected / 16 at risk

Adverse event: BMI increase normal/overweight to Obese
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increase in BMI from normal/overweight to any Obese category
Frequency: 5 affected / 16 at risk

Adverse event: LDL or Triglyceride increase
Serious: no
Organ System: Cardiac disorders
Notes: increase from normal to high in either LDL or Triglyceride
Frequency: 4 affected / 16 at risk

Adverse event: TD early signs
Serious: no
Organ System: Nervous system disorders
Notes: Early signs of mild tardive dyskinesia
Frequency: 1 affected / 16 at risk

Adverse event: Prolactin related symptom
Serious: no
Organ System: Endocrine disorders
Notes: Symptom related to prolactin level
Frequency: 2 affected / 16 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: psychiatric hospitalization
Frequency: 1 affected / 12 at risk

Adverse event: LDL or Triglyceride increase
Serious: no
Organ System: Cardiac disorders
Notes: increase from normal to high in either LDL or Triglyceride
Frequency: 5 affected / 12 at risk

Adverse event: Prolactin related symptom
Serious: no
Organ System: Endocrine disorders
Notes: Symptom related to prolactin level
Frequency: 2 affected / 12 at risk
Study: NCT00333437

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient was hospitalized
Frequency: 1 affected / 7 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient was unable to tolerate full dose of study drug because of GI distress
Frequency: 1 affected / 7 at risk
Study: NCT00333801

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 43 at risk

Adverse event: Severe Staph Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Motor Vehicle Accident complications
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Medical Stabilization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Abnormally high blood pressure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 43 at risk

Adverse event: Severe migraine headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Injury to finger
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Alcohol withdrawal
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 43 at risk

Adverse event: Cyst underarm
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 42 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypertrophy adnoids
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 42 at risk
Study: NCT00333970

Adverse event: worsening of psychiatric symptoms
Serious: yes
Organ System: Psychiatric disorders
Notes: all determined not to be study related
Frequency: 1 affected / 50 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Notes: determined not to be study related
Frequency: 1 affected / 50 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: determined not to be study related
Frequency: 1 affected / 50 at risk

Adverse event: worsening of psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: determined not to be study related
Frequency: 2 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: determined not to be study related
Frequency: 1 affected / 50 at risk

Adverse event: toe pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: determined not to be study related
Frequency: 1 affected / 50 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: participant reported to ER complaining of shortness of breath; determined not to be study related
Frequency: 1 affected / 25 at risk

Adverse event: pulled chest muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: presented to ER with chest pain diagnosed as pulled chest muscle; determined not to be study related
Frequency: 1 affected / 25 at risk

Adverse event: worsening of psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: determined not to be study related
Frequency: 2 affected / 25 at risk

Adverse event: Substance use
Serious: no
Organ System: Psychiatric disorders
Notes: determined not to be study related
Frequency: 3 affected / 25 at risk
Study: NCT00333983

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: One participant experienced non-study related renal failure. One participant experienced non-study related medical status change. One participant experienced non-study related hip fracture after fall at home.
Frequency: 2 affected / 20 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: One participant experienced non-study related renal failure. One participant experienced non-study related medical status change. One participant experienced non-study related hip fracture after fall at home.
Frequency: 1 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One participant with shouler pain in the study arm limiting participation in traditional upper extremity exercise.
Frequency: 1 affected / 21 at risk
Study: NCT00334113

Adverse event: Cardiac symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: Various symptoms including angina, chest pain, MI
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: UTI that resulted in hospitalization
Frequency: 1 affected / 32 at risk

Adverse event: hypoglycemia that resulted in hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 32 at risk

Adverse event: fever of unknown origin that resulted in hospitalizaton
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: orthopedic pain/injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: various pains in legs and feet were reported
Frequency: 6 affected / 32 at risk

Adverse event: bronchitis/pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Cardiac symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: Various symptoms including angina, chest pain, MI
Frequency: 4 affected / 34 at risk

Adverse event: tonsillar cancer that resulted in hospitalizaton
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 34 at risk

Adverse event: small stroke that resulted in hospitalization
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: orthopedic pain/injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: various pains in legs and feet were reported
Frequency: 2 affected / 34 at risk

Adverse event: bronchitis/pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk
Study: NCT00334542

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Generalized muscle pain/weakness
Frequency: 5 affected / 50 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Generalized muscle pain/weakness
Frequency: 5 affected / 50 at risk