RESULTS
Patient characteristics
From February 2009 to August 2010, 278 patients were referred
to us for inclusion. Twenty patients did not meet all the inclusion
and exclusion criteria. Seven refused to give informed consent
to take part, and five refused to continue the study after
the baseline assessment (n = 32). A total of 246 patients were
randomized and included in the ITT analysis set: 120 to the placebo
group and 126 to the oxycodone/paracetamol group. Ten
patients in the placebo group dropped out. Six patients exited
because their background analgesics changed due to pain aggravation,
and four because of progression of malignant neoplasia.
Eleven patients in the oxycodone/paracetamol group withdrew.
Four patients exited because of disease exacerbation, two
because of change in their background analgesics, and five
because of treatment-related adverse events. No statistically significant
difference was found in the dropout rates between the
two groups (Fisher’s exact test, P = 0Æ547). Thus, 225 patients
completed the trial (Fig. 1).
RESULTS
Patient characteristics
From February 2009 to August 2010, 278 patients were referred
to us for inclusion. Twenty patients did not meet all the inclusion
and exclusion criteria. Seven refused to give informed consent
to take part, and five refused to continue the study after
the baseline assessment (n = 32). A total of 246 patients were
randomized and included in the ITT analysis set: 120 to the placebo
group and 126 to the oxycodone/paracetamol group. Ten
patients in the placebo group dropped out. Six patients exited
because their background analgesics changed due to pain aggravation,
and four because of progression of malignant neoplasia.
Eleven patients in the oxycodone/paracetamol group withdrew.
Four patients exited because of disease exacerbation, two
because of change in their background analgesics, and five
because of treatment-related adverse events. No statistically significant
difference was found in the dropout rates between the
two groups (Fisher’s exact test, P = 0Æ547). Thus, 225 patients
completed the trial (Fig. 1).
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