Study: NCT00711971

Adverse event: Neonatal ICU Admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 40 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 42 at risk

Adverse event: Maternal ICU admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Maternal ICU admission
Frequency: 1 affected / 42 at risk

Adverse event: Aftertaste
Serious: no
Organ System: Gastrointestinal disorders
Notes: Aftertaste (sometimes described as fishy, as lemon, as strawberry or just "aftertaste"
Frequency: 7 affected / 42 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 42 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 42 at risk

Adverse event: Infant Jaundice
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 42 at risk

Adverse event: Preterm Contractions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 42 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 42 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 42 at risk

Adverse event: Neonatal ICU Admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 38 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 42 at risk

Adverse event: Aftertaste
Serious: no
Organ System: Gastrointestinal disorders
Notes: Aftertaste (sometimes described as fishy, as lemon, as strawberry or just "aftertaste"
Frequency: 8 affected / 42 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 42 at risk

Adverse event: Infant Jaundice
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Mastitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Preterm Contractions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 42 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 42 at risk

Adverse event: Neonatal ICU Admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 41 at risk

Adverse event: Aftertaste
Serious: no
Organ System: Gastrointestinal disorders
Notes: Aftertaste (sometimes described as fishy, as lemon, as strawberry or just "aftertaste"
Frequency: 7 affected / 42 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 42 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 42 at risk

Adverse event: Infant Jaundice
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Preterm Contractions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk