Study: NCT00417482

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Pulmonary Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Fall or Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Extrapyramidal signs
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 13 affected / 70 at risk

Adverse event: akathisia or restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 4 affected / 70 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 7 affected / 70 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 3 affected / 70 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 4 affected / 70 at risk

Adverse event: Agitation-Aggression
Serious: no
Organ System: Nervous system disorders
Notes: Agitation-aggression was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 70 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: Fall was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 2 affected / 70 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea or vomiting was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 2 affected / 70 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neurologic Event
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Agitation-Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pulmonary Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Extrapyramidal signs
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 4 affected / 40 at risk

Adverse event: akathisia or restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 6 affected / 40 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 5 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 40 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 4 affected / 40 at risk

Adverse event: Agitation-Aggression
Serious: no
Organ System: Nervous system disorders
Notes: Agitation-aggression was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 40 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Notes: Fall was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 40 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea or vomiting was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 2 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Extrapyramidal signs
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 4 affected / 13 at risk

Adverse event: akathisia or restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 1 affected / 13 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea or vomiting was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 2 affected / 13 at risk

Adverse event: Extrapyramidal signs
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 4 affected / 27 at risk

Adverse event: akathisia or restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 3 affected / 27 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 27 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 3 affected / 27 at risk

Adverse event: Agitation-Aggression
Serious: no
Organ System: Nervous system disorders
Notes: Agitation-aggression was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 27 at risk

Adverse event: Extrapyramidal signs
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 2 affected / 13 at risk

Adverse event: akathisia or restlessness
Serious: no
Organ System: Nervous system disorders
Notes: Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale.
Frequency: 1 affected / 13 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Notes: Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk

Adverse event: Agitation-Aggression
Serious: no
Organ System: Nervous system disorders
Notes: Agitation-aggression was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk

Adverse event: nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea or vomiting was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS).
Frequency: 1 affected / 13 at risk