Study: NCT01872338

Adverse event: Psychatric Adverse Events
Serious: yes
Organ System: Psychiatric disorders
Frequency: 26 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Cardiac disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 3 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Endocrine disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 2 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Gastrointestinal disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 2 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: General disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Nervous system disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 2 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 66 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Surgical and medical procedures
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 3 affected / 66 at risk

Adverse event: SAE Other
Serious: yes
Organ System: Social circumstances
Notes: \*\*no adverse events were determined by IRB to be related to the research\*\*
Frequency: 1 affected / 66 at risk

Adverse event: Psychiatric other (not including serious)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 66 at risk

Adverse event: Psychatric Adverse Events
Serious: yes
Organ System: Psychiatric disorders
Frequency: 37 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Cardiac disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 3 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Gastrointestinal disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: General disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Infections and infestations
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 2 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Nervous system disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: Medical SAE
Serious: yes
Organ System: Vascular disorders
Notes: \*\*no adverse events were determined by IRB to be related to the research procedures or intervention
Frequency: 1 affected / 69 at risk

Adverse event: SAE Other
Serious: yes
Organ System: Social circumstances
Notes: \*\*no adverse events were determined by IRB to be related to the research\*\*
Frequency: 2 affected / 69 at risk

Adverse event: Psychiatric other (not including serious)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 69 at risk