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The open-label extension studies required that participants had completed at least two weeks of treatment in the preceding double-blind study and met criteria for continuation in the study.
Accordingly, it is necessary to fully consider the criteria for continuation and discontinuation of the vaccine and formulate a study plan when conducting clinical studies of cancer peptide vaccines.
Criteria for continuation of treatment were: leukocytes >3000 /mm, neutrophils >1500 /mm, thrombocytes >7.5 × 10 /mm; alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin and creatinine levels less than two times the upper limit of normal (ULN); vomiting, nausea and diarrhea less than grade 1; and hand foot syndrome less than grade 2 for chemotherapy.
Additional criteria for continuation of treatment included serum magnesium levels >0.7 mg/dL and cetuximab-related dermatological adverse events less than grade 2. When there was a delay in treatment of >14 days, treatment according to the study protocol was discontinued.
An independent data monitoring committee conducted an end-of-phase II analysis of data from the HORIZON programme, which showed that cediranib 20 mg day−1 met all of the predefined criteria for continuation of the HORIZON II study; all subsequent patients were randomised 2 : 1 to the cediranib 20 mg or placebo treatment arms.
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The only data available is from Rothrock et al., where 68% of patients continued to receive treatment after two years, although these patients were receiving treatment through insurance reimbursement and criteria for the continuation of treatment remains unclear[31].
Imputation was performed with the multiple imputation by chained equations (MICE) package also in R. 24 For the analyses of relapse rates, we included all responders (HAM-D ≤8 or ≥50% reduction in symptoms) who met the original criteria for entry to the continuation phase of the study.
A negative sputum smear on direct sputum examination at the end of the intensive phase of treatment is equally used as criteria for the transition to the continuation phase [ 2, 3].
Of these, approximately six hundred individuals presented for continuation of treatment and were assessed for eligibility criteria.
Support for continuation was dominant.
4. Provide recommendations for continuation.
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