Study: NCT01731171

Adverse event: Psychiatric rehospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 33 at risk

Adverse event: Hospitalization after a fall
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: This single SAE was a hospitalization for a fall due to hyponatremia.
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal Illness/Condition
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 33 at risk

Adverse event: Cardiovascular Illness/Condition
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Genitourinary Illness/Conition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: Metabolic and/or Endocrine Illness/Condition
Serious: no
Organ System: Endocrine disorders
Notes: Although these are classified as metabolic and/or endocrine illness/condition in the trial, all AEs in this category fell under Endocrine.
Frequency: 3 affected / 33 at risk

Adverse event: Musculoskeletal Illness/Condition
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 33 at risk

Adverse event: Neurological or Sensory Illness/Condition
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 33 at risk

Adverse event: Respiratory Illness/Condition
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 33 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Dental Illness/Condition
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dermatological Illness/Condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Psychiatric rehospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 17 affected / 33 at risk

Adverse event: Gastrointestinal Illness/Condition
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 33 at risk

Adverse event: Cardiovascular Illness/Condition
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 33 at risk

Adverse event: Genitourinary Illness/Conition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 33 at risk

Adverse event: Musculoskeletal Illness/Condition
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Neurological or Sensory Illness/Condition
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 33 at risk

Adverse event: Respiratory Illness/Condition
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 33 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Dental Illness/Condition
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dermatological Illness/Condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk