Study: NCT01904032

Adverse event: Severe abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe abdominal pain resulting in inpatient hospitalization
Frequency: 1 affected / 64 at risk

Adverse event: Laparoscopic cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Unplanned laparoscopic cholecystectomy resulting in an inpatient hospitalization
Frequency: 1 affected / 64 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hiatal hernia resulting in an inpatient hospitalization
Frequency: 1 affected / 64 at risk

Adverse event: Cancer Diagnosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 64 at risk

Adverse event: Right total knee replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unplanned right total knee replacement resulting in an inpatient hospitalization
Frequency: 1 affected / 64 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 64 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 64 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Generalized Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 64 at risk

Adverse event: Upper Respiratory Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Abnormal Kidney Function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 64 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Routine Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 64 at risk

Adverse event: Worsening Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 64 at risk

Adverse event: Worsening Diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 64 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Lower Extremity Cramps
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Generalized Soreness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 11 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Right sided weakness
Serious: yes
Organ System: Nervous system disorders
Notes: Right sided weakness resulting in an inpatient hospitalization
Frequency: 1 affected / 65 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke resulting in an inpatient hospitalization
Frequency: 1 affected / 65 at risk

Adverse event: Acoustic neuroma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Severe abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Severe abdominal pain resulting in inpatient hospitalization
Frequency: 1 affected / 65 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 65 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Unplanned pregnancy considered an important medical event
Frequency: 1 affected / 65 at risk

Adverse event: Left tibia fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left tibia fracture resulting in an inpatient hospitalization
Frequency: 1 affected / 65 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 65 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 65 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 65 at risk

Adverse event: Generalized Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 65 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Upper Respiratory Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 65 at risk

Adverse event: Abnormal Kidney Function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 65 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 65 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 11 affected / 65 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 65 at risk

Adverse event: Routine Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 65 at risk

Adverse event: Worsening Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 65 at risk

Adverse event: Worsening Diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 65 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 65 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Lower Extremity Cramps
Serious: no
Organ System: General disorders
Frequency: 2 affected / 65 at risk

Adverse event: Menstrual Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 65 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 65 at risk

Adverse event: Generalized Soreness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 65 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 6 affected / 65 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 6 affected / 65 at risk