Study: NCT00928187

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Abnormal serum enzyme levels
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 152 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Infectious gastroenteritis and colitis, unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Unspecified malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Mixed hepatocellular cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 152 at risk

Adverse event: Other disorders of urinary system
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 152 at risk

Adverse event: Cutaneous abscess, furuncle and carbuncle
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Agranulocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 152 at risk

Adverse event: Other functional intestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 152 at risk

Adverse event: Gastrointestinal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 152 at risk

Adverse event: Abdominal and pelvic pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 152 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 17 affected / 152 at risk

Adverse event: Fever of other and unknown origin
Serious: no
Organ System: General disorders
Frequency: 9 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 152 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 11 affected / 152 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 8 affected / 152 at risk

Adverse event: Pain, not elsewhere classified
Serious: no
Organ System: General disorders
Frequency: 9 affected / 152 at risk

Adverse event: Symptoms and signs concerning food and fluid intake
Serious: no
Organ System: General disorders
Frequency: 28 affected / 152 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 152 at risk

Adverse event: Infectious gastroenteritis and colitis, unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 152 at risk

Adverse event: Unspecified malaria
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 152 at risk

Adverse event: Contraceptive management
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 152 at risk

Adverse event: Pregnancy examination and test
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 152 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 152 at risk

Adverse event: Other joint disorders, not elsewhere classified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 152 at risk

Adverse event: Other polyneuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 152 at risk

Adverse event: Other inflammation of vagina and vulva
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 152 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 152 at risk

Adverse event: Acute nasopharyngitis [common cold]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 152 at risk

Adverse event: Influenza, virus not identified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 152 at risk

Adverse event: Cutaneous abscess, furuncle and carbuncle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 152 at risk

Adverse event: Lichen simplex chronicus and prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 152 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 152 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 145 at risk

Adverse event: Unspecified diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 145 at risk

Adverse event: Other functional intestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Abdominal and pelvic pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Abnormal findings on diagnostic imaging of lung
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Cough
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Elevated blood glucose level
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 145 at risk

Adverse event: Pain in throat and chest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 145 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 145 at risk

Adverse event: Respiratory tuberculosis, not confirmed bacteriologically or histologically
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Extrapulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 145 at risk

Adverse event: Medical observation and evaluation for suspected diseases and conditions
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 145 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 145 at risk

Adverse event: Salpingitis and oophoritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 145 at risk

Adverse event: Bacterial pneumonia, not elsewhere classified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Pneumonia in diseases classified elsewhere
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 145 at risk

Adverse event: Agranulocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 145 at risk

Adverse event: Other functional intestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 145 at risk

Adverse event: Gastrointestinal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 145 at risk

Adverse event: Abdominal and pelvic pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 145 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 11 affected / 145 at risk

Adverse event: Fever of other and unknown origin
Serious: no
Organ System: General disorders
Frequency: 8 affected / 145 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 145 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 145 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 13 affected / 145 at risk

Adverse event: Pain, not elsewhere classified
Serious: no
Organ System: General disorders
Frequency: 5 affected / 145 at risk

Adverse event: Symptoms and signs concerning food and fluid intake
Serious: no
Organ System: General disorders
Frequency: 24 affected / 145 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 145 at risk

Adverse event: Infectious gastroenteritis and colitis, unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 145 at risk

Adverse event: Unspecified malaria
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 145 at risk

Adverse event: Contraceptive management
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 145 at risk

Adverse event: Pregnancy examination and test
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 145 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 145 at risk

Adverse event: Other joint disorders, not elsewhere classified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 145 at risk

Adverse event: Other polyneuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 145 at risk

Adverse event: Other inflammation of vagina and vulva
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 145 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 145 at risk

Adverse event: Acute nasopharyngitis [common cold]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 145 at risk

Adverse event: Influenza, virus not identified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 145 at risk

Adverse event: Cutaneous abscess, furuncle and carbuncle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 145 at risk

Adverse event: Lichen simplex chronicus and prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 145 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 145 at risk

Adverse event: Other anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 154 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Abnormalities of breathing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cough
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Fever of other and unknown origin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pain in throat and chest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Symptoms and signs concerning food and fluid intake
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Other septicaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Respiratory tuberculosis, bacteriologically and histologically confirmed
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Unspecified severe protein- calorie malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 154 at risk

Adverse event: Other abnormal products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Acute tubulo-interstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Unspecified renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Excessive, frequent and irregular menstruation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 154 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bacterial pneumonia, not elsewhere classified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Respiratory failure, not elsewhere classified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Lichen simplex chronicus and prurigo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Agranulocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 154 at risk

Adverse event: Other functional intestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 154 at risk

Adverse event: Gastrointestinal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Abdominal and pelvic pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 154 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 16 affected / 154 at risk

Adverse event: Fever of other and unknown origin
Serious: no
Organ System: General disorders
Frequency: 4 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 154 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 154 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 154 at risk

Adverse event: Pain, not elsewhere classified
Serious: no
Organ System: General disorders
Frequency: 5 affected / 154 at risk

Adverse event: Symptoms and signs concerning food and fluid intake
Serious: no
Organ System: General disorders
Frequency: 11 affected / 154 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 154 at risk

Adverse event: Infectious gastroenteritis and colitis, unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 154 at risk

Adverse event: Unspecified malaria
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 154 at risk

Adverse event: Contraceptive management
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 154 at risk

Adverse event: Pregnancy examination and test
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 154 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 154 at risk

Adverse event: Other joint disorders, not elsewhere classified
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 154 at risk

Adverse event: Other polyneuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 154 at risk

Adverse event: Other inflammation of vagina and vulva
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 154 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 154 at risk

Adverse event: Acute nasopharyngitis [common cold]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 154 at risk

Adverse event: Influenza, virus not identified
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 154 at risk

Adverse event: Cutaneous abscess, furuncle and carbuncle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 154 at risk

Adverse event: Lichen simplex chronicus and prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 154 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 154 at risk