Study: NCT01720667

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 4 hypotension thought probably or possibly due to study medications
Frequency: 4 affected / 42 at risk

Adverse event: Respiratory Abnormality
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4 respiratory distress thought probably or possibly due to study medication
Frequency: 1 affected / 42 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Specific finding of hypotension on a day on which an adverse event was indicated.
Frequency: 7 affected / 42 at risk

Adverse event: Heart Rate Abnormailty
Serious: no
Organ System: Cardiac disorders
Notes: Specific finding of heart rate abnormality on a day on which an adverse event was reported
Frequency: 1 affected / 42 at risk

Adverse event: Respiratory Abnormality
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Specific finding of respiratory abnormality documented on a day on which an adverse event was documented
Frequency: 12 affected / 42 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Specific finding of sedation on a day on which an adverse event was documented
Frequency: 8 affected / 42 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Specific finding of poor feeding on a day on which adverse event was documented
Frequency: 7 affected / 42 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Specific finding of infection on a day on which adverse event was documented
Frequency: 3 affected / 42 at risk

Adverse event: New Medical Problem
Serious: no
Organ System: General disorders
Notes: New Medical Problem reported on a day where an adverse event is documented
Frequency: 6 affected / 42 at risk

Adverse event: New Medications
Serious: no
Organ System: General disorders
Frequency: 7 affected / 42 at risk

Adverse event: Vasopressor Requirement
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension requiring vasopressor support on at least one day
Frequency: 13 affected / 42 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 4 hypotension thought probably or possibly due to study medications
Frequency: 1 affected / 64 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Specific finding of hypotension on a day on which an adverse event was indicated.
Frequency: 3 affected / 64 at risk

Adverse event: Heart Rate Abnormailty
Serious: no
Organ System: Cardiac disorders
Notes: Specific finding of heart rate abnormality on a day on which an adverse event was reported
Frequency: 3 affected / 64 at risk

Adverse event: Respiratory Abnormality
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Specific finding of respiratory abnormality documented on a day on which an adverse event was documented
Frequency: 8 affected / 64 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Specific finding of sedation on a day on which an adverse event was documented
Frequency: 7 affected / 64 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Specific finding of poor feeding on a day on which adverse event was documented
Frequency: 6 affected / 64 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Specific finding of infection on a day on which adverse event was documented
Frequency: 2 affected / 64 at risk

Adverse event: New Medical Problem
Serious: no
Organ System: General disorders
Notes: New Medical Problem reported on a day where an adverse event is documented
Frequency: 5 affected / 64 at risk

Adverse event: New Medications
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Vasopressor Requirement
Serious: no
Organ System: Cardiac disorders
Notes: Hypotension requiring vasopressor support on at least one day
Frequency: 10 affected / 64 at risk