Study: NCT01183689

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 202 at risk

Adverse event: Obstetric
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 202 at risk

Adverse event: Elective breast surgery
Serious: yes
Organ System: General disorders
Notes: Elective breast surgery
Frequency: 1 affected / 202 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 202 at risk

Adverse event: Muscoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 202 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 202 at risk

Adverse event: Gall bladder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 202 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 202 at risk

Adverse event: Obstetric
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 202 at risk

Adverse event: Weight loss related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: General disorders
Frequency: 26 affected / 202 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 56 affected / 202 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Gall bladder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Stomach pain related to gallstones
Frequency: 3 affected / 200 at risk

Adverse event: Obstetric
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 200 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for stomach virus
Frequency: 1 affected / 200 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Rheumatoid arthritis - increased pain following pregnancy -- condition was present 10 years prior to study entry
Frequency: 1 affected / 200 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 200 at risk

Adverse event: Muscoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 200 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gall bladder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 200 at risk

Adverse event: Ashthma Attack
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Obstetric
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 200 at risk

Adverse event: Weight loss related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: General disorders
Frequency: 28 affected / 200 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 40 affected / 200 at risk

Adverse event: Gall bladder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Stomach pain related to gallstones
Frequency: 1 affected / 197 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant was hospitalized 3 times for depression. One participant was hospitalized twice for paranoid schizophrenia. One other participant was hospitalized once for depression.
Frequency: 3 affected / 197 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Infections and infestations
Notes: Tonsillectomy
Frequency: 1 affected / 197 at risk

Adverse event: E-coli bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization for E-coli bacterial infection
Frequency: 1 affected / 197 at risk

Adverse event: Benign mass
Serious: yes
Organ System: General disorders
Notes: Outpatient surgery for benign mass on left maxillary sinus
Frequency: 1 affected / 197 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Syncope led to fall and hospitalization for concussion
Frequency: 1 affected / 197 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for Crohn's disease
Frequency: 1 affected / 197 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 197 at risk

Adverse event: Muscoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 197 at risk

Adverse event: Gall bladder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 197 at risk

Adverse event: Ashthma Attack
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 197 at risk

Adverse event: Obstetric
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 197 at risk

Adverse event: Weight loss related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 197 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: General disorders
Frequency: 27 affected / 197 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 54 affected / 197 at risk