Table 4.
Post-discontinuation adverse events to evaluate opioid withdrawal potential
| Patients with event, n (%) | All patients (N = 1109) |
|---|---|
| Any PDAE associated with opioid withdrawal | 109 (9.8) |
| PDAEs associated with opioid withdrawal occurring in ≥3 patients | |
| Insomnia | 22 (2.0) |
| Headache | 18 (1.6) |
| Diarrhea | 13 (1.2) |
| Anxiety | 12 (1.1) |
| Irritability | 10 (0.9) |
| Nausea | 9 (0.8) |
| Rhinorrhea | 9 (0.8) |
| Hyperhidrosis | 8 (0.7) |
| Pain | 8 (0.7) |
| Restlessness | 8 (0.7) |
| Arthralgia | 6 (0.5) |
| Drug withdrawal syndrome | 4 (0.4) |
| Yawning | 4 (0.4) |
| Chills | 3 (0.3) |
Adverse events were coded by preferred terms and system organ class using the Medical Dictionary for Regulatory Activities, version 19.0. A full list of preferred terms evaluated are in the Supplementary Materials
PDAE post-discontinuation adverse event