Study: NCT01932801

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: One SAE was ascribed to the study procedures: difficulties ambulating due to an injection site hematoma that led to an emergency department visit, which precipitated alcohol withdrawal and subsequent hospital admission.
Frequency: 13 affected / 77 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: no association with procedures
Frequency: 3 affected / 77 at risk

Adverse event: Decresed appetite
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 77 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: One SAE was ascribed to the study procedures: difficulties ambulating due to an injection site hematoma that led to an emergency department visit, which precipitated alcohol withdrawal and subsequent hospital admission.
Frequency: 17 affected / 79 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: Decresed appetite
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: depressive symptoms
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 79 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: One SAE was ascribed to the study procedures: difficulties ambulating due to an injection site hematoma that led to an emergency department visit, which precipitated alcohol withdrawal and subsequent hospital admission.
Frequency: 19 affected / 78 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 78 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 78 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 78 at risk

Adverse event: Insomnia
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 78 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: One SAE was ascribed to the study procedures: difficulties ambulating due to an injection site hematoma that led to an emergency department visit, which precipitated alcohol withdrawal and subsequent hospital admission.
Frequency: 17 affected / 74 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 74 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 74 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 74 at risk

Adverse event: Somnolence
Serious: no
Organ System: Product Issues
Notes: Event reported during study timeline that did not occur at baseline
Frequency: 1 affected / 74 at risk