Study: NCT02148211

Adverse event: Cleft lip and palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: This SAE is reported in infant.
Frequency: 1 affected / 507 at risk

Adverse event: Congenital cystic kidney disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: This SAE is reported in infant.
Frequency: 1 affected / 507 at risk

Adverse event: Injection site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 507 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 507 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 507 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 507 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 507 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 507 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 507 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 507 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 507 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 507 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 507 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 507 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 507 at risk

Adverse event: Multiple allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 507 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 507 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 507 at risk

Adverse event: Contraindicated product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 507 at risk

Adverse event: Expired product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 507 at risk

Adverse event: Exposure during pregnancy
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The inclusion of this in the AE table is a function of the coding convention of the medical coding system.
Frequency: 503 affected / 507 at risk

Adverse event: Exposure via body fluid
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 507 at risk

Adverse event: Extra dose administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 507 at risk

Adverse event: Maternal exposure before pregnancy
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The inclusion of this in the AE table is a function of the coding convention of the medical coding system.
Frequency: 1 affected / 507 at risk

Adverse event: Maternal exposure during pregnancy
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The inclusion of this in the AE table is a function of the coding convention of the medical coding system.
Frequency: 2 affected / 507 at risk

Adverse event: Maternal exposure timing unspecified
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The inclusion of this in the AE table is a function of the coding convention of the medical coding system.
Frequency: 1 affected / 507 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 507 at risk

Adverse event: Wrong product administered
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 507 at risk

Adverse event: Wrong technique in product usage process
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 507 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 507 at risk

Adverse event: Neuritis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 507 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 507 at risk

Adverse event: Arrested labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 507 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 507 at risk

Adverse event: Live birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 103 affected / 507 at risk

Adverse event: Low birth weight baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 507 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 507 at risk

Adverse event: Premature delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 507 at risk

Adverse event: Prolonged pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 507 at risk

Adverse event: Twin pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 507 at risk

Adverse event: Umbilical cord around neck
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 507 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 507 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 507 at risk