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Most common treatment-emergent adverse events were diarrhea (55.3%) and nausea (42.1%), a majority of which were of grade 1 severity.
Hypertension, diarrhea, hair depigmentation, and nausea were the most frequent drug-related adverse events, the majority of which were of grade 1/2.
The study of emulsification time showed that all four formulations employed could emulsify within the range of (17 30) second and were of grade A class (Table 9).
None of the solicited local symptoms reported in either group were of grade 3 intensity.
All unsolicited adverse events were of Grade 1 or Grade 2 intensity and all resolved during the study period.
The majority of out of range ALT and bilirubin values were of grade 1 intensity, occurring with a similar incidence in the two groups.
All general solicited adverse events were of Grade 1 or Grade 2 intensity and resolved during the 8-day follow-up period.
All systemic solicited symptoms were of Grade 1 or Grade 2 intensity and all resolved during the 7-day follow-up period.
The majority of abnormal values of hemoglobin, white blood cells and platelets were of grade 1 intensity and occurred with similar incidence in the two groups.
Most treatment-related adverse events were of grade 1.
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All visual function AEs were of
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