Study: NCT00303446

Adverse event: fall requiring hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: cardiac events
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 25 at risk

Adverse event: constitutional symptoms
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: ear-nose-throat
Serious: no
Organ System: General disorders
Frequency: 11 affected / 25 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: hematologic
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: infectious
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 25 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: General disorders
Frequency: 18 affected / 25 at risk

Adverse event: neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 25 at risk

Adverse event: genitourinary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: fall requiring hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Death from a probable cardiac event.
Frequency: 1 affected / 25 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dehydration requiring hospitalization.
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject developed serious respiratory difficulties and was removed from the study.
Frequency: 1 affected / 25 at risk

Adverse event: cardiac events
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: constitutional symptoms
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 25 at risk

Adverse event: ear-nose-throat
Serious: no
Organ System: General disorders
Frequency: 10 affected / 25 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: hematologic
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 25 at risk

Adverse event: infectious
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 25 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: General disorders
Frequency: 11 affected / 25 at risk

Adverse event: neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 25 at risk

Adverse event: genitourinary
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk