Study: NCT00850993

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Jaundice
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 17 at risk

Adverse event: Acne infantile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Carbon dioxide decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Erythema toxicum neonatorum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Rash neonatal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Jaundice
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk