Study: NCT00194987

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 51 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: 1 aseptic meningitis
Frequency: 4 affected / 51 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: requiring hospitalization
Frequency: 2 affected / 51 at risk

Adverse event: HELLP
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: hypertension liver low platelets
Frequency: 1 affected / 51 at risk

Adverse event: thrombosis, venous
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Peripheral Intravenous Catheter thrombosis
Frequency: 1 affected / 51 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: delivery prior to 35 weeks of gestation
Frequency: 4 affected / 51 at risk

Adverse event: jaw tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: past history
Frequency: 1 affected / 51 at risk

Adverse event: IVIG dose error
Serious: no
Organ System: Product Issues
Notes: once each: 10 grams and 120 grams
Frequency: 2 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 51 at risk

Adverse event: bells palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: 1 aseptic meningitis
Frequency: 2 affected / 51 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: requiring hospitalization
Frequency: 4 affected / 51 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 51 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: delivery prior to 35 weeks of gestation
Frequency: 3 affected / 51 at risk

Adverse event: IVIG dose error
Serious: no
Organ System: Product Issues
Notes: once each: 10 grams and 120 grams
Frequency: 2 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 51 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: delivery prior to 35 weeks of gestation
Frequency: 4 affected / 51 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: delivery prior to 35 weeks of gestation
Frequency: 3 affected / 51 at risk