Study: NCT00589914

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 606 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 606 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 606 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Depressive symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 606 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 606 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 15 affected / 606 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 606 at risk

Adverse event: Tension
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 606 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 606 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 606 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 606 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 57 affected / 606 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 608 at risk

Adverse event: Volvulus of small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 608 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 608 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 608 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 608 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 608 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 608 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 608 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 608 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 608 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 608 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 608 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 608 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 608 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 608 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 608 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 608 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 608 at risk