Study: NCT00439374

Adverse event: Miscarriage or stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, antepartum stillbirth, intrapartum stillbirth
Frequency: 5 affected / 327 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 327 at risk

Adverse event: Pregnancy Complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: advanced cervical dilation, oligohydramnios, preterm rupture of the membranes
Frequency: 3 affected / 327 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 327 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Notes: Nosebleed
Frequency: 1 affected / 327 at risk

Adverse event: Maternal Pulmonary edema
Serious: yes
Organ System: Cardiac disorders
Notes: due to anemia and cardiac insufficiency
Frequency: 1 affected / 327 at risk

Adverse event: Maternal blood disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pulmonary embolism, thrombocytopenia
Frequency: 2 affected / 327 at risk

Adverse event: Congenital Anomalies
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: ovarian cyst, esophageal atresia, flexion contracture, hypospadias, patent ductus arteriosis, polydactyly, torticollis, Trisomy 21
Frequency: 5 affected / 327 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 327 at risk

Adverse event: Neonatal Hematochromatosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 327 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 326 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 326 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 326 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 326 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Reaction at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 217 affected / 326 at risk

Adverse event: Sore/burn at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 145 affected / 326 at risk

Adverse event: Itching at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 121 affected / 326 at risk

Adverse event: Swelling/lump at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 107 affected / 326 at risk

Adverse event: Bruising at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 326 at risk

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 326 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 326 at risk

Adverse event: Miscarriage or stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, antepartum stillbirth, intrapartum stillbirth
Frequency: 1 affected / 330 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 330 at risk

Adverse event: Pregnancy Complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: advanced cervical dilation, oligohydramnios, preterm rupture of the membranes
Frequency: 3 affected / 330 at risk

Adverse event: Congenital Anomalies
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: ovarian cyst, esophageal atresia, flexion contracture, hypospadias, patent ductus arteriosis, polydactyly, torticollis, Trisomy 21
Frequency: 3 affected / 330 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 330 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 328 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 328 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 328 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 328 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 328 at risk

Adverse event: Reaction at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 210 affected / 328 at risk

Adverse event: Sore/burn at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 153 affected / 328 at risk

Adverse event: Itching at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 109 affected / 328 at risk

Adverse event: Swelling/lump at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 328 at risk

Adverse event: Bruising at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 328 at risk

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 328 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 328 at risk