Study: NCT00993031

Adverse event: Death, natural causes
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 194 at risk

Adverse event: Abruptio-placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 194 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 194 at risk

Adverse event: Severe anemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 194 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 194 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 194 at risk

Adverse event: Intra-uterine fetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 194 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 194 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 194 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 194 at risk

Adverse event: Anaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 194 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 194 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 194 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 194 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 194 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 194 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 194 at risk

Adverse event: Dysphagia/odynophagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 194 at risk

Adverse event: Dyspnea/respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 194 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 194 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 194 at risk

Adverse event: Fatigue/malaise
Serious: no
Organ System: General disorders
Frequency: 33 affected / 194 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 194 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 194 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 194 at risk

Adverse event: Neurosensory alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 194 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 58 affected / 194 at risk

Adverse event: Pain, general
Serious: no
Organ System: General disorders
Frequency: 15 affected / 194 at risk

Adverse event: Pallor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 194 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 194 at risk

Adverse event: Pre-term premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 194 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 194 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 194 at risk

Adverse event: Rash (non-infectious)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 194 at risk

Adverse event: Reduced WBC count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 194 at risk

Adverse event: Serum glucose, low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 194 at risk

Adverse event: Temperature, elevated
Serious: no
Organ System: General disorders
Frequency: 10 affected / 194 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 194 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 194 at risk

Adverse event: Urine Protein
Serious: no
Organ System: Renal and urinary disorders
Frequency: 41 affected / 194 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 194 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 194 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 195 at risk

Adverse event: Complicated malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 195 at risk

Adverse event: Deep venous Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 195 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 195 at risk

Adverse event: Severe anemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 195 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 195 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 195 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 195 at risk

Adverse event: Intra-uterine fetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 195 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 195 at risk

Adverse event: Preterm contractions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 195 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 195 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 195 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 195 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 195 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 195 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 195 at risk

Adverse event: Anaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 195 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 195 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 195 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 195 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 195 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 195 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 195 at risk

Adverse event: Dysphagia/odynophagia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 195 at risk

Adverse event: Dyspnea/respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 195 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 195 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 195 at risk

Adverse event: Fatigue/malaise
Serious: no
Organ System: General disorders
Frequency: 26 affected / 195 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 195 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 195 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 195 at risk

Adverse event: Neurosensory alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 195 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 62 affected / 195 at risk

Adverse event: Oral sores
Serious: no
Organ System: General disorders
Frequency: 1 affected / 195 at risk

Adverse event: Pain, general
Serious: no
Organ System: General disorders
Frequency: 16 affected / 195 at risk

Adverse event: Pallor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Pre-term premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 195 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 195 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 195 at risk

Adverse event: Rash (non-infectious)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 195 at risk

Adverse event: Reduced WBC count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 195 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Serum glucose, low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Temperature, elevated
Serious: no
Organ System: General disorders
Frequency: 7 affected / 195 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 195 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 195 at risk

Adverse event: Urine Protein
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 195 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 195 at risk