Table 2.
Abnormal UDT results reported versus investigator risk assessment for misuse, abuse, and diversion
| Misuse | Investigator risk assessment level
|
|||
|---|---|---|---|---|
| Low (N=575) | Moderate (N=97) | High (N=11) | Total (N=684a) | |
| Patients with ≥1 abnormal UDT result at Visit 1b, n (%) | 128 (22.3) | 26 (26.8) | 5 (45.5) | 160 (23.4) |
| Patients positive for illicit substance | 37 (6.4) | 11 (11.3) | 3 (27.3) | 51 (7.5) |
| Patients negative for expected opioid use | 101 (17.6) | 18 (18.6) | 2 (18.2) | 122 (17.8) |
| Patients who completed Visit 3, n | 301 | 45 | 5 | 351 |
| Patients with ≥1 abnormal UDT result at Visit 3c, n (%) | 83 (27.6) | 16 (35.6) | 2 (40.0) | 101 (28.8) |
| Patients positive for illicit substance | 18 (6.0) | 5 (11.1) | 1 (20.0) | 24 (6.8) |
| Patients positive for unaccounted opioid | 70 (23.3) | 14 (31.1) | 1 (20.0) | 85 (24.2) |
| Patients negative for expected opioid use | 11 (3.7) | 0 (0.0) | 0 (0.0) | 11 (3.1) |
| Abuse | Low (N=610) | Moderate (N=61) | High (N=12) | Total (N=684a) |
| Patients with ≥1 abnormal UDT result at Visit 1b, n (%) | 136 (22.3) | 19 (31.1) | 4 (33.3) | 160 (23.4) |
| Patients positive for illicit substance | 40 (6.6) | 9 (14.8) | 2 (16.7) | 51 (7.5) |
| Patients negative for expected opioid use | 107 (17.5) | 12 (19.7) | 2 (16.7) | 122 (17.8) |
| Patients who completed Visit 3, n | 319 | 26 | 6 | 351 |
| Patients with ≥1 abnormal UDT result at Visit 3c, n (%) | 92 (28.8) | 7 (26.9) | 2 (33.3) | 101 (28.8) |
| Patients positive for illicit substance | 21 (6.6) | 3 (11.5) | 0 (0.0) | 24 (6.8) |
| Patients positive for unaccounted opioid | 78 (24.5) | 5 (19.2) | 2 (33.3) | 85 (24.2) |
| Patients negative for expected opioid use | 11 (3.4) | 0 (0.0) | 0 (0.0) | 11 (3.1) |
| Diversion | Low (N=643) | Moderate (N=32) | High (N=7) | Total (N=684a) |
| Patients with ≥1 abnormal UDT result at Visit 1b, n (%) | 143 (22.2) | 13 (40.6) | 3 (42.9) | 160 (23.4) |
| Patients positive for illicit substance | 44 (6.8) | 6 (18.8) | 1 (14.3) | 51 (7.5) |
| Patients negative for expected opioid use | 111 (17.3) | 8 (25.0) | 2 (28.6) | 122 (17.8) |
| Patients who completed Visit 3, n | 336 | 11 | 3 | 351 |
| Patients with ≥1 abnormal UDT result at Visit 3c, n (%) | 97 (28.9) | 4 (36.4) | 0 (0.0) | 101 (28.8) |
| Patients positive for illicit substance | 23 (6.8) | 1 (9.1) | 0 (0.0) | 24 (6.8) |
| Patients positive for unaccounted opioid | 82 (24.4) | 3 (27.3) | 0 (0.0) | 85 (24.2) |
| Patients negative for expected opioid use | 11 (3.3) | 0 (0.0) | 0 (0.0) | 11 (3.1) |
Notes:
a
Includes patients who were missing assignment of risk level, 1 for abuse, 1 for misuse, and 2 for diversion;
b
percentage is calculated using the number of patients in each risk category (low, moderate, high, total) as the denominator;
c
percentage is calculated using the number of patients who completed Visit 3 within each risk category (low, moderate, high, total) as the denominator.
Abbreviation: UDT, urine drug test.