Patient-Reported Outcomes |
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Overall preference (primary endpoint) |
“Which of the pre-filled syringes would you prefer from now on?” |
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Patient satisfaction |
“How would you assess, in summary, the small/large syringe at the end of the study?” |
Five categories were suggested: “very poor”, “poor”, “no preference”, “good” and “very good”. |
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Syringe with or without pre-attached needle
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“How do you like the pre-attached needle (small syringe) in comparison to one that still has to be attached (large syringe)?”
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Five categories were suggested: “great disadvantage”, “disadvantage”, “no difference”, “advantage”, and “great advantage”. |
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Usability of syringe volume
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“Do you feel comfortable with the fact that the injection liquid is five times less in the small syringe than in the large syringe?”
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Five possible answers were suggested: “fully disagree”, ”disagree”, ”indifferent”, “agree” and “fully agree”. |
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Local tolerability
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Occurrence of erythema, swelling, itching, pain and haematoma assessed as “none”, “mild”, “moderate” or “severe”. |
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Usability of the 10 mg/ml syringe at the 2nd and 3rd injection (MC formulation) and of the 50 mg/ml syringe at the 5th and 6th injection (HC formulation)
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Rated on a visual scale from 0 (not convenient = 0 mm) to 10 (very convenient = 100 mm). |
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Physician-Reported Outcomes |
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Usability of the 10 mg/ml syringe at the 1st injection (MC formulation) and of the 50 mg/ml syringe at the 4th injection (HC formulation)
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Rated on a visual scale from 0 (not convenient = 0 mm) to 10 (very convenient = 100 mm). |
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Local tolerability
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Occurrence of erythema, swelling, itching, pain and haematoma assessed as “none”, “mild”, “moderate” or “severe”. |
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Study Nurse/Physician-Reported Outcomes |
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Syringe with or without pre-attached needle
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“How do you like the pre-attached needle (small syringe) in comparison to the one which still has to be attached (large syringe)?”
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Five categories were suggested: “great disadvantage”, “disadvantage”, “no difference”, “advantage”, and “great advantage”. |
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Usability of syringe volume
|
“Do you feel comfortable with the fact that the injection liquid is five times less in the small syringe than in the large syringe?”
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Five possible answers were suggested: “fully disagree”, ”disagree”, ”indifferent”, “agree” and “fully agree”. |
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Overall assessment of the small prefilled syringe
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Five categories were suggested: “very poor”, “poor”, “no preference”, “good” and “very good”. |
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Overall assessment of the large prefilled syringe
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Five categories were suggested: “very poor”, “poor”, “no preference”, “good” and “very good”. |