Study: NCT01588236

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: considered not related to study drug as SAE occurred 30 days after the last study drug dose.
Frequency: 1 affected / 88 at risk

Adverse event: any TEAE
Serious: no
Organ System: Investigations
Frequency: 23 affected / 88 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 88 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 88 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 88 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: considered not related to study drug as SAE occurred 30 days after the last study drug dose.
Frequency: 1 affected / 90 at risk

Adverse event: any TEAE
Serious: no
Organ System: Investigations
Frequency: 23 affected / 90 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 90 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 90 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 90 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Considered not related to study drug
Frequency: 1 affected / 91 at risk

Adverse event: any TEAE
Serious: no
Organ System: Investigations
Frequency: 32 affected / 91 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 91 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 91 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 6 affected / 91 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 91 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 91 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 91 at risk