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Three patients had to be excluded from evaluation for dose definition because of major protocol deviations.
One subject from the placebo group was excluded from the per protocol analysis because of major protocol violations.
Thirty patients were excluded from the efficacy analysis of this report, 15 because of major protocol violations and 15 because of premature discontinuation.
Of 412 patients in the intention-to-treat population, a total of 35 patients were excluded because of major protocol deviations during the study.
Two patients were considered ineligible because of major protocol violations (discontinuation of chemotherapy after one cycle and withdrawal of informed consent, n=1; pre-existing coronary heart disease, n=1).
The per protocol population excluded 24 FAS patients because of major protocol deviations (1 screening failure in the CSII group and 23 patients in the PRT group who failed to wear glucose sensors at least 70% of the time).
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Further, to address the possible impact of major protocol violations, an additional 'per-protocol' population was defined excluding all subjects with premature discontinuation or major protocol violations.
Three patients in Group A (two never received chemotherapy and one because of a major protocol violation) and four patients in Group B (two never received chemotherapy, one was treated with RT because of superior vena cava syndrome and one for a major protocol violation) were not evaluable.
Because of major treatment protocol deviations, the effect of adjuvant chemotherapy is still somewhat controversial.
There were a total of 96 major protocol violations.
Withdrawal criteria were withdrawal of consent, appearance of other species of Plasmodium or major protocol violation.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com