Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Pharmacokinetic variable
- Plasma levels of phenytoin (values expressed in mcg/mL): Measuring time: At the beginning and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours after administration.
Key secondary outcomes:
- Presence of adverse events (AE)
- distribution frequency for the appearance of adverse events (Yes, No),
- type of event (name of the AE),
- duration (time from appearance to end of the event),
- severity (severe, non-severe), intensity of AE (grades 1-5),
- relation of causality (remote, possible, probable, very probable),
- result of AE (recuperate, improvement, persist or sequels),
- attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: At each administration and during the whole study.
Clinical laboratory tests:
- Hematology (hemoglobin, hematocrit, erythrocytes count, white blood cells counts, platelet count) and
- Biochemistry (glycemia, cholesterol, triglycerides, transaminases, alkaline phosphatase, urea, creatinine, total proteins, total bilirubin) determinations (numerical values as units of measurement for each determination).
Measuring time: At the beginning and end of the study.
- Vital signs (body temperature in degrees centigrade, heart rate in beats / minute, blood pressure in mm Hg and respiration rate in breaths per minute). Measuring time: Prior to administration of the tablets, during the first 4 hours after administration, and at the end of each period.