TABLE 3.
Rates of Related Immediate Post Injection Reaction or Injection Site Pruritus During the Induction Phase in the SALOME Clinical Trial
| Related immediate post injection reaction or injection site pruritus | |||||||
| iOAT | Period | N Pt.* | Total Injections | Injection Days | Events N (per Pt.) | Rate/100 injections | Rate/100 days |
| Diacetylmorphine | Induction | 102 | 43,349 | 16,376 | 7 (7) | 0.784 | 2.115 |
| After Induction | 102 | 893 | 331 | 70 (26) | 0.161 | 0.427 | |
| Hydromorphone | Induction | 100 | 40,018 | 16,259 | 5 (5) | 0.588 | 1.529 |
| After Induction | 98 | 851 | 327 | 108 (16) | 0.270 | 0.664 | |
iOAT, (injectable opioid agonist treatment); N, number; Pt., patient; SALOME, Study to Assess Longer Term Opioid Medication Effectiveness.
Related refers to any adverse drug reaction classified as possibly, probably or definitely related to the study medication.
SALOME was a randomized non-inferiority clinical trial, where diacetylmorphine and hydromorphone were provided double-blind.
*Lower number of patients after induction represent patients that completed induction but did not receive treatment afterwards (N = 2 hydromorphone).