Study: NCT00160199

Adverse event: Adnexa uteri mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Acnes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 113 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 11 affected / 113 at risk

Adverse event: Breast signs and symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 113 at risk

Adverse event: Flatulence Bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 113 at risk

Adverse event: Fungal infection NEC
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 113 at risk

Adverse event: Gastrointestinal and Abdominal Pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 113 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 113 at risk

Adverse event: Musculoskeletal and connective tissue signs and symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 113 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 113 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 113 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 107 at risk

Adverse event: Acnes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 107 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 7 affected / 107 at risk

Adverse event: Breast signs and symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 107 at risk

Adverse event: Flatulence Bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 107 at risk

Adverse event: Fungal infection NEC
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 107 at risk

Adverse event: Gastrointestinal and Abdominal Pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 107 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 107 at risk

Adverse event: Musculoskeletal and connective tissue signs and symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 107 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 107 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 107 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 107 at risk