Study: NCT01138995

Adverse event: stroke/high blood pressure
Serious: yes
Organ System: Cardiac disorders
Notes: non device related
Frequency: 1 affected / 98 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: non device related
Frequency: 1 affected / 98 at risk

Adverse event: pneumonia/respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: non-device related
Frequency: 1 affected / 98 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Immune system disorders
Notes: non-device related
Frequency: 1 affected / 98 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: non device related
Frequency: 2 affected / 98 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: non device related
Frequency: 1 affected / 98 at risk

Adverse event: localized skin redness, rash, irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 98 at risk

Adverse event: Eye irritation and hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 98 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: hypertonia, headache, dizziness, memory deficit
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Nausea or abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Hypertension and/or flushing
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 98 at risk

Adverse event: Fear or depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: gout or diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: Atrial fibrillation or abnormal heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: asthma, cough, bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: blister, folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: fall with or without injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 45 affected / 98 at risk

Adverse event: stroke/high blood pressure
Serious: yes
Organ System: Cardiac disorders
Notes: non device related
Frequency: 3 affected / 99 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: pneumonia/respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: non-device related
Frequency: 1 affected / 99 at risk

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: non device related
Frequency: 3 affected / 99 at risk

Adverse event: kidney damage due to dehydration
Serious: yes
Organ System: Renal and urinary disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: anemia requiring blood transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: Ovarian mass
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: methicillin resistant Staphylococcus aureus
Serious: yes
Organ System: Infections and infestations
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: mental depression and anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: hospitalization general complaints
Serious: yes
Organ System: General disorders
Notes: non device related
Frequency: 1 affected / 99 at risk

Adverse event: localized skin redness, rash, irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 99 at risk

Adverse event: hypertonia, headache, dizziness, memory deficit
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 99 at risk

Adverse event: Nausea or abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hypertension and/or flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 99 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 99 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fear or depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 99 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 99 at risk

Adverse event: Atrial fibrillation or abnormal heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: asthma, cough, bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Renal mass
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 99 at risk

Adverse event: blister, folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 99 at risk

Adverse event: fall with or without injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 56 affected / 99 at risk