Study: NCT00719186

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 376 at risk

Adverse event: Carcinoma of the Skin-stage 3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 376 at risk

Adverse event: Heterotopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Pregnancy of unknown location
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 376 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 376 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 376 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 376 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 170 affected / 355 at risk

Adverse event: abdominal/pelvic pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 138 affected / 355 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 355 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 117 affected / 355 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 76 affected / 355 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 53 affected / 355 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 64 affected / 355 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 355 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 355 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 355 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 355 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 355 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 355 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 355 at risk

Adverse event: Joint/limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 355 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 355 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 355 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 355 at risk

Adverse event: Acne/ oily skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 355 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 355 at risk

Adverse event: Abnormal vaginal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 355 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 355 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 355 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 355 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 355 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 355 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 355 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 355 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 355 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 355 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 355 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 355 at risk

Adverse event: Sinus complaints
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 355 at risk

Adverse event: First Trimester other complication during pregnancy
Serious: no
Organ System: General disorders
Frequency: 8 affected / 355 at risk

Adverse event: Second Trimester Hyperemesis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 355 at risk

Adverse event: Second Trimester Gestational Diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 355 at risk

Adverse event: Second Trimester Pre-eclampsia/ eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 355 at risk

Adverse event: Second Trimester pretem labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 355 at risk

Adverse event: Second Trimester Premature rupture of membrane
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 355 at risk

Adverse event: Second Trimester Incompetant cervix
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 355 at risk

Adverse event: Post-partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 355 at risk

Adverse event: Post-partum Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 355 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 355 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 355 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 374 at risk

Adverse event: Ruptured Corpus Luteum Cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 374 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 374 at risk

Adverse event: Pregnancy of unknown location
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 374 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 374 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 374 at risk

Adverse event: Mid ureteral stone
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 374 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 374 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 374 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 374 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 374 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 167 affected / 359 at risk

Adverse event: abdominal/pelvic pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 146 affected / 359 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 359 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 73 affected / 359 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 76 affected / 359 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 78 affected / 359 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 60 affected / 359 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 359 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 359 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 359 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 359 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 359 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 359 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 359 at risk

Adverse event: Joint/limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 359 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 359 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 359 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 359 at risk

Adverse event: Acne/ oily skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 359 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 359 at risk

Adverse event: Abnormal vaginal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 18 affected / 359 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 359 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 359 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 359 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 359 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 359 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 359 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 359 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 359 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 359 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 359 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 359 at risk

Adverse event: Sinus complaints
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 359 at risk

Adverse event: First Trimester other complication during pregnancy
Serious: no
Organ System: General disorders
Frequency: 15 affected / 359 at risk

Adverse event: Second Trimester Hyperemesis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 359 at risk

Adverse event: Second Trimester Gestational Diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 27 affected / 359 at risk

Adverse event: Second Trimester Pre-eclampsia/ eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 359 at risk

Adverse event: Second Trimester pretem labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 359 at risk

Adverse event: Second Trimester Premature rupture of membrane
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 359 at risk

Adverse event: Second Trimester Incompetant cervix
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 359 at risk

Adverse event: Post-partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 359 at risk

Adverse event: Post-partum Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 359 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 27 affected / 359 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 359 at risk