To analyze the impact of silibinin treatment on blood leukocytes and MDSCs in tumor-bearing animals, mice were periodically bled and the numbers of blood leukocytes monitored after tumor inoculation.
However, no significant differences were observed in the operative time, amount of bleeding, and number of intraoperative complications.
Data concerning the treatment type (e.g., conservative, laparoscopic, open surgery, conversions, cholecystostomy, and choledochotomies), surgical durations, elective vs. emergency operations, complications, bleeding and number of re-operations were collected from the patients records.
Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity.
Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity.
Additional endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, the rate of surgical reintervention for abnormal uterine bleeding, and the mean number of days to return to normal activity.
Additional endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), the rate of surgical reintervention for abnormal uterine bleeding, and the mean number of days to return to normal activity.
In populations where risk of bleeding is lower, the number of bleeding events is so small that it is impractical to measure them in the same study.
A decrease in the platelet count can result in bleeding if the number falls to a value below 20,000 platelets per microlitre.
It is noteworthy that despite the higher total number of bleeding events, the number of fatal bleeding events was similar to that in the rest of the population, both during the infusion period (0.6% versus 0.4%) and over the 28-day period (0.6% versus 0.8%) [ 36].
