Study: NCT00974246

Adverse event: Mental Status Change
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject was sent to the Emergency Department for mental status changes. He was admitted for tests and observation. He was stabilized and discharged to the Nursing Home.
Frequency: 1 affected / 27 at risk

Adverse event: Increased Agitation with Combative Behaviors
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject was sent to the Emergency Department for increased agitation with combative behaviors. She was admitted for observation and psychiatric treatment. She was stabilized and discharged to the Nursing Home.
Frequency: 1 affected / 27 at risk

Adverse event: Left Above the Knee Amputation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject was sent to Emergency Department for possible Deep Vein Thrombosis (DVT). It was determined that she did have a DVT but it was too late to save the leg. An amputation was performed. Subject was stabilized \& discharged to the Nursing Home.
Frequency: 1 affected / 27 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 27 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 27 at risk

Adverse event: Bilateral Lower Extremity Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pruitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Right Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Increased Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Increased Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 27 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk