Safety
The prevalence of patients with AEs and/or SAEs
A comparative analysis of Group 1 and 2 patients in terms of AEs and SAEs revealed significant differences between the study groups (Pearson's chi-square test, p=0.00001).
- No opioid-related AEs nor addiction with Taphalgin;
- Taphalgin alleviates opioid-related AEs;
- No dose-limiting AEs in trials;
- No respiratory depression
- A favorable choice for patients at high risk of AEs or substance abuse.
A statistically significantly higher number of patients who discontinued treatment due to adverse events was revealed in morphine group (Pearson's chi-square test, p=0.01):
Group 1 (Taphalgin) = 0.0 % (0/120),
Group 2 (morphine) = 5.1 % (3/59).
The clinical studies showed both: a very good safety profile of Taphalgin, solution for subcutaneous injection, and comparable efficacy with oral morphine.
