Study: NCT02432209

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 188 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization during first trimester
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 63 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 63 at risk

Adverse event: Pregnancy of unknown location
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 3 affected / 63 at risk

Adverse event: Marginal Placenta Previa
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 63 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: For those who achieved pregnancy
Frequency: 2 affected / 63 at risk

Adverse event: Hospitalization-infant
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 1 affected / 38 at risk

Adverse event: Meningomyelocele
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 1 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 188 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 35 affected / 188 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 188 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 188 at risk

Adverse event: Mood swings
Serious: no
Organ System: General disorders
Frequency: 2 affected / 188 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: General disorders
Frequency: 41 affected / 188 at risk

Adverse event: Oily stools/discharge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 188 at risk

Adverse event: Pre-term labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 2 affected / 63 at risk

Adverse event: Pre-eclampsia/Eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 4 affected / 63 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 6 affected / 63 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 2 affected / 63 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 2 affected / 63 at risk

Adverse event: Placental abnormalities
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 5 affected / 63 at risk

Adverse event: Other complication
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 4 affected / 63 at risk

Adverse event: Other post-partum complication(s)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 3 affected / 63 at risk

Adverse event: Intrauterine growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 1 affected / 38 at risk

Adverse event: Admission to NICU
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 7 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 188 at risk

Adverse event: Anxiety/irritability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 188 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 188 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 23 affected / 188 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Complex cyst resulting in surgical intervention
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 2 affected / 59 at risk

Adverse event: Pregnancy of unknown location
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 3 affected / 59 at risk

Adverse event: Placenta Previa and Pre-term birth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 59 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: For those who achieved pregnancy
Frequency: 1 affected / 59 at risk

Adverse event: Hospitalization-infant
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 2 affected / 42 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Constipation
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 191 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 9 affected / 191 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Mood swings
Serious: no
Organ System: General disorders
Frequency: 9 affected / 191 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: General disorders
Frequency: 24 affected / 191 at risk

Adverse event: Pre-term labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 6 affected / 59 at risk

Adverse event: Pre-eclampsia/Eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 7 affected / 59 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 10 affected / 59 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 4 affected / 59 at risk

Adverse event: Placental abnormalities
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 4 affected / 59 at risk

Adverse event: Post-partum Infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 2 affected / 59 at risk

Adverse event: Post-partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 59 at risk

Adverse event: Other complication
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 3 affected / 59 at risk

Adverse event: Other post-partum complication(s)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For those who achieved pregnancy
Frequency: 1 affected / 59 at risk

Adverse event: Intrauterine growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 4 affected / 42 at risk

Adverse event: Admission to NICU
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: For the live-born infants
Frequency: 12 affected / 42 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 191 at risk

Adverse event: Anxiety/irritability
Serious: no
Organ System: General disorders
Frequency: 14 affected / 191 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 191 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 25 affected / 191 at risk