Study: NCT00975780

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 19 affected / 434 at risk

Adverse event: Skin / Soft Tissue Event
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 434 at risk

Adverse event: Respiratory Difficulty
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 434 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: Defined as a study participant falling down; the resulting injury leading to hospitalization.
Frequency: 16 affected / 434 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 434 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 434 at risk

Adverse event: Abnormal Blood Glucose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 434 at risk

Adverse event: Acute Chest Pain/Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 434 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 33 affected / 434 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 434 at risk

Adverse event: Blood Pressure Alteration
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 434 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 434 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: These Serious Adverse Events were those that led to hospitalization that were otherwise not specified. Given the characteristics of the study population (age, environment), hospitalization is not uncommon.
Frequency: 38 affected / 434 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death (unrelated to intervention)
Frequency: 125 affected / 434 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 156 affected / 434 at risk

Adverse event: Skin / Soft Tissue Event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 271 affected / 434 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 81 affected / 434 at risk

Adverse event: Respiratory Difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 238 affected / 434 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 143 affected / 434 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 161 affected / 434 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 98 affected / 434 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 76 affected / 434 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 434 at risk

Adverse event: Oral Cavity Disturbance
Serious: no
Organ System: General disorders
Frequency: 51 affected / 434 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 36 affected / 434 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 33 affected / 434 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 434 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 434 at risk

Adverse event: Generalized Malaise
Serious: no
Organ System: General disorders
Frequency: 31 affected / 434 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 400 at risk

Adverse event: Skin / Soft Tissue Event
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 400 at risk

Adverse event: Eye infection
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 400 at risk

Adverse event: Respiratory Difficulty
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 400 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: Defined as a study participant falling down; the resulting injury leading to hospitalization.
Frequency: 20 affected / 400 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 400 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 400 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 400 at risk

Adverse event: Abnormal Blood Glucose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 400 at risk

Adverse event: Acute Chest Pain/Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 400 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 22 affected / 400 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 400 at risk

Adverse event: Blood Pressure Alteration
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 400 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 400 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 400 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 400 at risk

Adverse event: Generalize Malaise
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 400 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: These Serious Adverse Events were those that led to hospitalization that were otherwise not specified. Given the characteristics of the study population (age, environment), hospitalization is not uncommon.
Frequency: 22 affected / 400 at risk

Adverse event: Unrelated and Unanticipated OTHER
Serious: yes
Organ System: General disorders
Notes: Unrelated and unanticipated OTHER events deemed to be Serious Adverse Events.
Frequency: 2 affected / 400 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death (unrelated to intervention)
Frequency: 95 affected / 400 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 130 affected / 400 at risk

Adverse event: Skin / Soft Tissue Event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 217 affected / 400 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 66 affected / 400 at risk

Adverse event: Respiratory Difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 228 affected / 400 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 138 affected / 400 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 400 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 400 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 400 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 400 at risk

Adverse event: Oral Cavity Disturbance
Serious: no
Organ System: General disorders
Frequency: 55 affected / 400 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 21 affected / 400 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 400 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 400 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 400 at risk

Adverse event: Generalized Malaise
Serious: no
Organ System: General disorders
Frequency: 18 affected / 400 at risk