Study: NCT00970944

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 87 at risk

Adverse event: Other Neurologic
Serious: yes
Organ System: Nervous system disorders
Notes: Bilateral subdural fluid collection, arm and head tremor
Frequency: 1 affected / 87 at risk

Adverse event: Other Gastrointestinal Problems
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI bleeding, gastritis, bowel obstruction, colon carcinoma, peritonitis
Frequency: 2 affected / 87 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 87 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 87 at risk

Adverse event: General Medical Problems
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Hypertonia / Spasticity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 87 at risk

Adverse event: Insomnia / Sleep Disturbance
Serious: no
Organ System: General disorders
Frequency: 12 affected / 87 at risk

Adverse event: Agitation / Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 87 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Does not include urinary tract infection
Frequency: 10 affected / 87 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 87 at risk

Adverse event: General Medical Problems
Serious: no
Organ System: General disorders
Frequency: 9 affected / 87 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Intracranial Hemorrage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Other Neurologic
Serious: yes
Organ System: Nervous system disorders
Notes: Bilateral subdural fluid collection, arm and head tremor
Frequency: 1 affected / 97 at risk

Adverse event: Hypoarousal/Lethargy/Somnolence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Autonomic Storm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Other Gastrointestinal Problems
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI bleeding, gastritis, bowel obstruction, colon carcinoma, peritonitis
Frequency: 3 affected / 97 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 97 at risk

Adverse event: General Medical Problems
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 97 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Other Abnormal Laboratory
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 97 at risk

Adverse event: Hypertonia / Spasticity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 97 at risk

Adverse event: Insomnia / Sleep Disturbance
Serious: no
Organ System: General disorders
Frequency: 14 affected / 97 at risk

Adverse event: Agitation / Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 97 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Does not include urinary tract infection
Frequency: 15 affected / 97 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 97 at risk

Adverse event: General Medical Problems
Serious: no
Organ System: General disorders
Frequency: 11 affected / 97 at risk