Study: NCT02061280

Adverse event: Acute chest syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was scheduled for planned cholecystectomy and while hospitalized had significant post operative pain and developed acute chest syndrome.
Frequency: 1 affected / 53 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: Nervous system disorders
Notes: Patient complained of headache lasting several weeks then developed unsteady gait. Hospitalized and given IV fluids, Toradol and Compazine with complete resolution at discharge.
Frequency: 1 affected / 53 at risk

Adverse event: Skin bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 53 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 53 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 53 at risk

Adverse event: Muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 22 affected / 53 at risk

Adverse event: Increased or irregular heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 53 at risk

Adverse event: Restlessness or nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 53 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 53 at risk

Adverse event: Runny nose and congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 53 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant expressed hopelessness, despair, and thoughts of suicide to her guidance counselor. She was admitted to the hospital under the Baker Act for 72 hours. Followup with psychiatrist as an outpatient.
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Runny nose and congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk