Figures & data
Figure 1 Risk assessment questionnaire.
Note:
aOpioid Risk Tool (ORT), Screener and Opioid Assessment for Patients with Pain (SOAPP), and Current Opioid Misuse Measure (COMM).
Figure 2 Patients’ responses on the self-reported misuse, abuse, and diversion questionnaire.
Figure 3 Patient disposition.
Notes:
aOne patient completed Visit 3 but did not have Visit 5 or officially discontinue. Therefore, he is not counted as discontinuing the study, although he did not complete the maintenance phase; bmore than one subcategory could be indicated.
Abbreviation: AE, adverse event.
Abbreviation: AE, adverse event.
Figure 4 Risk levels based on the investigator risk assessment questionnaire reported at baseline.
Table 1 Crosstabulation of COMM score versus investigator risk assessment for misuse, abuse, and diversion
Figure 5 Positive urine drug test results at Visits 1 and 3.a,b
Notes:
aAbnormal results confirmed by quantitative testing; bno patients had positive results for phencyclidine or illicit amphetamine at either Visit 1 or Visit 3. Positive amphetamine results may be attributed to legitimate prescription use of amphetamine analogs.
Abbreviation: THC, tetrahydrocannabinol.
Abbreviation: THC, tetrahydrocannabinol.
Table 2 Abnormal UDT results reported versus investigator risk assessment for misuse, abuse, and diversion