. 2020 Apr 2;9(4):1003. doi: 10.3390/jcm9041003

Table 1.

Inclusion and exclusion criteria.

Inclusion Criteria	Exclusion Criteria
Adult male and female patients (≥18 years) of any ethnic origin with solid malignancy (any stage) Stable chronic background pain: baseline NRS ≤4 for more than 12 h a day in the previous week through ATC opioid therapy Patients who report suffering from BTcP crisis: 1 to 4 times a day in at least 1 of the 3 days before the start of the study Prescription of transmucosal fentanyl (any formulation) for the treatment of BTcP in doses effective according to the best supportive therapy and in accordance with the provisions of the relative SmPC, in absence of specific contraindications Basic therapy of chronic background pain through OMEDD of ≥60 mg Patient’s ability to understand and sign the informed consent Life expectancy of at least 30 days ECOG Performance Status 0 to 3	Intense episodic pain of a non-oncological nature Intense no-BTcP * ECOG Performance Status 4 Altered patient’s state of consciousness and/or inability to fill in the evaluation questionnaires Participation in an intervention clinical study Pregnancy or breastfeeding Contraindications to the use of opioids BTcP treatment already in place Patients with previous or current history of neurological/psychiatric disorder and/or any substance abuse (or dependence) ^ Any medical condition or situation complicating the collection of study data, as determined by the Investigator

Inclusion Criteria

Exclusion Criteria

Adult male and female patients (≥18 years) of any ethnic origin with solid malignancy (any stage)
Stable chronic background pain: baseline NRS ≤4 for more than 12 h a day in the previous week through ATC opioid therapy
Patients who report suffering from BTcP crisis: 1 to 4 times a day in at least 1 of the 3 days before the start of the study
Prescription of transmucosal fentanyl (any formulation) for the treatment of BTcP in doses effective according to the best supportive therapy and in accordance with the provisions of the relative SmPC, in absence of specific contraindications
Basic therapy of chronic background pain through OMEDD of ≥60 mg
Patient’s ability to understand and sign the informed consent
Life expectancy of at least 30 days
ECOG Performance Status 0 to 3

Intense episodic pain of a non-oncological nature
Intense no-BTcP *
ECOG Performance Status 4
Altered patient’s state of consciousness and/or inability to fill in the evaluation questionnaires
Participation in an intervention clinical study
Pregnancy or breastfeeding
Contraindications to the use of opioids
BTcP treatment already in place
Patients with previous or current history of neurological/psychiatric disorder and/or any substance abuse (or dependence) ^
Any medical condition or situation complicating the collection of study data, as determined by the Investigator

Notes: * End-dose pain or pain during titration of the opioid dose; ^ patients treated with antidepressants have been not excluded. Abbreviations: NRS, Numeric Rating Scale; ATC, around-the-clock; OMEDD, oral morphine equivalent daily doses; BTcP, breakthrough cancer pain; SmPC, summary of product characteristics; ECOG, Eastern Cooperative Oncology Group.