I'd consume far more than my allocated dose, then spend sleepless nights tossing and turning, my mind racing and heart pounding, only to wake up and take another pill with a coffee to compensate.
All patients received the allocated dose of 4-factor PCC at randomisation.
Following the 3-week titration stage, patients received their allocated dose for a period of 6 weeks.
For three days prior to visit 3, participants consumed their allocated dose of juice (70 mL) twice per day.
On weeks 1, 3, 5, 7, 9 and 11, etoposide was administered orally per allocated dose level (DL) as 10 doses in 5 days with b.i.d.
There was no evidence of an effect in the univariate analyses for allocated dose group and the factor was not included in the multivariate model.
The lack of separation in the observed efficacy between the higher MK-941 doses may be explained by the inability to uptitrate patients in the higher dose groups to their allocated dose because of risk or occurrence of hypoglycemia.
However, the first CYT997 infusion in this patient was stopped early after 17 h because of a thrombosis related to their peripherally inserted central catheter, and the second dose was the first given at the allocated dose level.
As with the intervention group, those participants in the control group who refuse to continue with the allocated dose of liquid oil will be offered fish oil capsules providing the equivalent dosage of EPA and DHA.
The allocated dose group was included in the univariate analyses for completeness and assurance, but excluded from the multivariate analyses: these analyses include only data from phase I of treatment, which was identically planned regardless of the allocated trial treatment (treatment differed in terms of the inclusion or not of phase II treatment).
