Study: NCT01864603

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1671 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 1671 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1671 at risk

Adverse event: Cutaneous Eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Elevated ALT
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1671 at risk

Adverse event: Elevated AST
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1671 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Genital Ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1671 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Poisoning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1671 at risk

Adverse event: Pre-term Labor
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1671 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1671 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 1671 at risk

Adverse event: Temperature
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1671 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1671 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Wound
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1671 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1671 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 1671 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 1671 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1671 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1671 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1671 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1671 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1671 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1671 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1671 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1671 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1671 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5447 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5447 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Pre-term Labor
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5447 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 5447 at risk

Adverse event: Blood clot in brain
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Cesarean Infant Delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5447 at risk

Adverse event: Head injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5447 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5447 at risk

Adverse event: Ruptured ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5447 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5447 at risk

Adverse event: Seroconversion
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 5447 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5447 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5447 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 5447 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5447 at risk

Adverse event: Stillbirth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 5447 at risk

Adverse event: Dizzinesss
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 5447 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5447 at risk