Study: NCT00388297

Adverse event: Chest/abdominal pain
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 339 at risk

Adverse event: Irregular fetal heart rate
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 339 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 339 at risk

Adverse event: Neonatal Severe Hearing Loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 339 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant reported side effect
Frequency: 18 affected / 338 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported side effect
Frequency: 3 affected / 338 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 4 affected / 338 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 4 affected / 338 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 10 affected / 338 at risk

Adverse event: Other side effects
Serious: no
Organ System: General disorders
Notes: Participant reported side effects including allergic reaction.
Frequency: 18 affected / 338 at risk

Adverse event: Hashimoto's thryoiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 338 at risk

Adverse event: IUGR, non-reassuring
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Non-reassuring Intrauterine Growth Restriction
Frequency: 1 affected / 338 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant reported side effect
Frequency: 8 affected / 336 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported side effect
Frequency: 5 affected / 336 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 3 affected / 336 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 4 affected / 336 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 8 affected / 336 at risk

Adverse event: Other side effects
Serious: no
Organ System: General disorders
Notes: Participant reported side effects including allergic reaction.
Frequency: 13 affected / 336 at risk

Adverse event: Maternal atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 265 at risk

Adverse event: Maternal death
Serious: yes
Organ System: General disorders
Notes: Maternal death at 2 years postpartum
Frequency: 1 affected / 265 at risk

Adverse event: Abnormal Doppler
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 265 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant reported side effect
Frequency: 10 affected / 261 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported side effect
Frequency: 2 affected / 261 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 2 affected / 261 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 4 affected / 261 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 3 affected / 261 at risk

Adverse event: Other side effects
Serious: no
Organ System: General disorders
Notes: Participant reported side effects including allergic reaction.
Frequency: 4 affected / 261 at risk

Adverse event: Neonatal Hypoxic-Ischemic Encephalopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hypoxic-Ischemic Encephalopathy
Frequency: 1 affected / 261 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant reported side effect
Frequency: 15 affected / 259 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported side effect
Frequency: 2 affected / 259 at risk

Adverse event: Nervousness
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 2 affected / 259 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 5 affected / 259 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Participant reported side effect
Frequency: 4 affected / 259 at risk

Adverse event: Other side effects
Serious: no
Organ System: General disorders
Notes: Participant reported side effects including allergic reaction.
Frequency: 10 affected / 259 at risk