Study: NCT00006164

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 517 at risk

Adverse event: Thrombocytopenia or pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 517 at risk

Adverse event: Atherosclerotic disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 517 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 517 at risk

Adverse event: Other cardiovascular or circulatory event
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 517 at risk

Adverse event: Nonvariceal gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 517 at risk

Adverse event: Hernia or intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 517 at risk

Adverse event: Other digestive system event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 517 at risk

Adverse event: Electrolyte, mineral, or water imbalance
Serious: yes
Organ System: Endocrine disorders
Frequency: 6 affected / 517 at risk

Adverse event: Diabetes and its complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 517 at risk

Adverse event: Thyroid disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 517 at risk

Adverse event: Renal or urinary diseases
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 517 at risk

Adverse event: Gynecologic, menstrual, or sexual disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 517 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 517 at risk

Adverse event: Other pancreatic or biliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 517 at risk

Adverse event: Liver-disease events other than primary or secondary outcomes
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Liver-disease events not related to death or other study-related clinical primary or secondary outcomes of the trial
Frequency: 1 affected / 517 at risk

Adverse event: Mucocutaneous infection and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 517 at risk

Adverse event: Respiratory tract infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 517 at risk

Adverse event: Systemic infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 517 at risk

Adverse event: Other infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 517 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 517 at risk

Adverse event: Drug reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 517 at risk

Adverse event: Liver-biopsy complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 517 at risk

Adverse event: Musculoskelatal surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 517 at risk

Adverse event: Arthritis or back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 517 at risk

Adverse event: Malignant neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 517 at risk

Adverse event: Benign neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 517 at risk

Adverse event: Cerebral aneurysm, infarct, or stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 517 at risk

Adverse event: Other neurologic event
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 517 at risk

Adverse event: Affective disorders or delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 517 at risk

Adverse event: Suicidal ideation or attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 517 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 517 at risk

Adverse event: Respiratory disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 517 at risk

Adverse event: Cardiovascular signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 10 affected / 517 at risk

Adverse event: Hepatobiliary signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 8 affected / 517 at risk

Adverse event: Neurologic signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 7 affected / 517 at risk

Adverse event: Digestive signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 4 affected / 517 at risk

Adverse event: Other general signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 4 affected / 517 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 517 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 517 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 33 affected / 517 at risk

Adverse event: Sexual dysfunction, impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 28 affected / 517 at risk

Adverse event: Cystitis, bladder infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 517 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 517 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Immune system disorders
Frequency: 27 affected / 517 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 517 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 517 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 136 affected / 517 at risk

Adverse event: Bursitis, tendonitis, enthesopathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 517 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 517 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 517 at risk

Adverse event: Muscle/back aches or pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 145 affected / 517 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 517 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 93 affected / 517 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 517 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 517 at risk

Adverse event: Diarrhea, loose stool
Serious: no
Organ System: General disorders
Frequency: 48 affected / 517 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 52 affected / 517 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 136 affected / 517 at risk

Adverse event: Dizziness, vertigo, light-headedness
Serious: no
Organ System: General disorders
Frequency: 42 affected / 517 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 77 affected / 517 at risk

Adverse event: Insomnia, sleep disturbance
Serious: no
Organ System: General disorders
Frequency: 92 affected / 517 at risk

Adverse event: Memory loss, confusion
Serious: no
Organ System: General disorders
Frequency: 58 affected / 517 at risk

Adverse event: Tingling, numbness
Serious: no
Organ System: General disorders
Frequency: 47 affected / 517 at risk

Adverse event: Nervousness, irritability
Serious: no
Organ System: General disorders
Frequency: 62 affected / 517 at risk

Adverse event: Nonproductive cough
Serious: no
Organ System: General disorders
Frequency: 34 affected / 517 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 26 affected / 517 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 71 affected / 517 at risk

Adverse event: Body aches, chills, fever
Serious: no
Organ System: General disorders
Frequency: 86 affected / 517 at risk

Adverse event: Fatigue, malaise, weakness
Serious: no
Organ System: General disorders
Frequency: 141 affected / 517 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 63 affected / 517 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 517 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 533 at risk

Adverse event: Atherosclerotic disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 533 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 533 at risk

Adverse event: Other cardiovascular or circulatory event
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 533 at risk

Adverse event: Nonvariceal gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 533 at risk

Adverse event: Hernia or intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 533 at risk

Adverse event: Other digestive system event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 533 at risk

Adverse event: Electrolyte, mineral, or water imbalance
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 533 at risk

Adverse event: Diabetes and its complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 533 at risk

Adverse event: Thyroid disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 533 at risk

Adverse event: Renal or urinary diseases
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 533 at risk

Adverse event: Gynecologic, menstrual, or sexual disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 533 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 533 at risk

Adverse event: Other pancreatic or biliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 533 at risk

Adverse event: Liver-disease events other than primary or secondary outcomes
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Liver-disease events not related to death or other study-related clinical primary or secondary outcomes of the trial
Frequency: 1 affected / 533 at risk

Adverse event: Mucocutaneous infection and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 533 at risk

Adverse event: Respiratory tract infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 533 at risk

Adverse event: Systemic infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 533 at risk

Adverse event: Other infections and infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 533 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 533 at risk

Adverse event: Drug reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 533 at risk

Adverse event: Liver-biopsy complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 533 at risk

Adverse event: Musculoskelatal surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 533 at risk

Adverse event: Arthritis or back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 533 at risk

Adverse event: Malignant neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 533 at risk

Adverse event: Benign neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 533 at risk

Adverse event: Cerebral aneurysm, infarct, or stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 533 at risk

Adverse event: Other neurologic event
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 533 at risk

Adverse event: Affective disorders or delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 533 at risk

Adverse event: Suicidal ideation or attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 533 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 533 at risk

Adverse event: Respiratory disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 533 at risk

Adverse event: Benign skin and nail disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 533 at risk

Adverse event: Cardiovascular signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 6 affected / 533 at risk

Adverse event: Hepatobiliary signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 6 affected / 533 at risk

Adverse event: Neurologic signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 6 affected / 533 at risk

Adverse event: Digestive signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 3 affected / 533 at risk

Adverse event: Other general signs or symptoms
Serious: yes
Organ System: General disorders
Notes: These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
Frequency: 8 affected / 533 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 533 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 533 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 56 affected / 533 at risk

Adverse event: Sexual dysfunction, impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 533 at risk

Adverse event: Cystitis, bladder infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 533 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 533 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Immune system disorders
Frequency: 23 affected / 533 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 533 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 533 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 533 at risk

Adverse event: Bursitis, tendonitis, enthesopathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 533 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 533 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 533 at risk

Adverse event: Muscle/back aches or pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 124 affected / 533 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 533 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 89 affected / 533 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 533 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 39 affected / 533 at risk

Adverse event: Diarrhea, loose stool
Serious: no
Organ System: General disorders
Frequency: 39 affected / 533 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 34 affected / 533 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 134 affected / 533 at risk

Adverse event: Dizziness, vertigo, light-headedness
Serious: no
Organ System: General disorders
Frequency: 31 affected / 533 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 44 affected / 533 at risk

Adverse event: Insomnia, sleep disturbance
Serious: no
Organ System: General disorders
Frequency: 54 affected / 533 at risk

Adverse event: Memory loss, confusion
Serious: no
Organ System: General disorders
Frequency: 37 affected / 533 at risk

Adverse event: Tingling, numbness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 533 at risk

Adverse event: Nervousness, irritability
Serious: no
Organ System: General disorders
Frequency: 23 affected / 533 at risk

Adverse event: Nonproductive cough
Serious: no
Organ System: General disorders
Frequency: 22 affected / 533 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 18 affected / 533 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 45 affected / 533 at risk

Adverse event: Body aches, chills, fever
Serious: no
Organ System: General disorders
Frequency: 49 affected / 533 at risk

Adverse event: Fatigue, malaise, weakness
Serious: no
Organ System: General disorders
Frequency: 121 affected / 533 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 533 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 70 affected / 533 at risk