Study: NCT01948050

Adverse event: Exacerbation of shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of shortness of breath and chest pain on 2 occasions in the follow-up period. Symptoms were attributed to opioid medication regimen and patient's anxiety, and the issue was resolved.
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Transient Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tongue tingling
Serious: no
Organ System: General disorders
Notes: Subject with diagnosis of cancer of the base of tongue; tongue tingling developed as a part of cancer treatment prior to study participation
Frequency: 1 affected / 16 at risk

Adverse event: Memory lapse
Serious: no
Organ System: Nervous system disorders
Notes: transient increase of memory lapse in elderly subject with history of CVA affecting frontal lobe.
Frequency: 1 affected / 16 at risk

Adverse event: Clear discharge from ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tibial fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: tibial fracture due to mechanical fall
Frequency: 1 affected / 16 at risk

Adverse event: Exacerbation of shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of shortness of breath and chest pain on 2 occasions in the follow-up period. Symptoms were attributed to opioid medication regimen and patient's anxiety, and the issue was resolved.
Frequency: 1 affected / 8 at risk

Adverse event: Exacerbation of Pain due to rectal cellulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Transient change in mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Interrupted Sleep
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Worsening of Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk