Study: NCT01008319

Adverse event: Blurry Vision/Double Vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vasomotor Flushes (hot flashes)
Serious: no
Organ System: Endocrine disorders
Notes: Hot Flashes
Frequency: 32 affected / 60 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: mood irritability
Frequency: 32 affected / 60 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 60 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 29 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 60 at risk

Adverse event: Blurry Vision/Double Vision
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 60 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 60 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Weight increased
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 60 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 60 at risk

Adverse event: Leg pain/leg swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Birth Defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 60 at risk

Adverse event: Blurry Vision/Double Vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vasomotor Flushes (hot flashes)
Serious: no
Organ System: Endocrine disorders
Notes: Hot Flashes
Frequency: 30 affected / 60 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: mood irritability
Frequency: 27 affected / 60 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 60 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 18 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 60 at risk

Adverse event: Blurry Vision/Double Vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 60 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Decreased urination frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Weight increased
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 60 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 60 at risk

Adverse event: Leg pain/leg swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 60 at risk