Study: NCT02539394

Adverse event: Skeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hardware Complication, Pseudoarthrosis
Frequency: 3 affected / 53 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: ABLA, Acute Cardiac, Arrhythmia, DVT, Hyperkalemia, Hypertension, Hyponatremia, Hypotension/Hypovolemia, Leukocytosis, VTE
Frequency: 17 affected / 53 at risk

Adverse event: Digestive
Serious: no
Organ System: General disorders
Notes: Dysphagia
Frequency: 1 affected / 53 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Urinary Retention
Frequency: 1 affected / 53 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, Dysphagia, Nausea / Vomiting, Reflux
Frequency: 24 affected / 53 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytosis
Frequency: 7 affected / 53 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness/Vertigo, Migraine
Frequency: 1 affected / 53 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Radicular, Radicular
Frequency: 19 affected / 53 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Aspiration, Atelectasis, Hypoxia
Frequency: 10 affected / 53 at risk

Adverse event: Wound
Serious: no
Organ System: Surgical and medical procedures
Notes: Hematoma, Infection, SSI
Frequency: 5 affected / 53 at risk

Adverse event: GastroIntestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Constipation, Dysphagia, Nausea / Vomiting, Reflux
Frequency: 1 affected / 56 at risk

Adverse event: Skeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hardware Complication, Pseudoarthrosis
Frequency: 2 affected / 56 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: ABLA, Acute Cardiac, Arrhythmia, DVT, Hyperkalemia, Hypertension, Hyponatremia, Hypotension/Hypovolemia, Leukocytosis, VTE
Frequency: 15 affected / 56 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia
Frequency: 6 affected / 56 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, Dysphagia, Nausea / Vomiting, Reflux
Frequency: 23 affected / 56 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytosis
Frequency: 9 affected / 56 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness/Vertigo, Migraine
Frequency: 3 affected / 56 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Non-Radicular, Radicular
Frequency: 28 affected / 56 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Aspiration, Atelectasis, Hypoxia
Frequency: 6 affected / 56 at risk

Adverse event: Wound
Serious: no
Organ System: Surgical and medical procedures
Notes: Hematoma, Infection, SSI
Frequency: 3 affected / 56 at risk