Sentence examples for as predefined in the protocol from inspiring English sources
As predefined in the protocol, all patients had received prior anthracycline therapy.
Only one patient did not receive 100% of prescribed chemotherapy and radiotherapy doses because of toxicity, and the maximum protocol cisplatin and docetaxel doses (DL6) were given without achieving a MTD as predefined in the trial protocol, as also observed by Pasini et al (2005) with a similar backbone and doses, but with the addition of infusional 5-FU.
As predefined in the study protocol, an exploratory Cox's regression analysis of survival and time to progression was used to adjust the treatment effect of thymostimulin or placebo according to the relative risks imposed by baseline characteristics.
As predefined in the study protocol, a stepwise backward Cox's regression analysis of survival was used to adjust the treatment effect according to relative risks imposed by baseline predictors.
Efficacy and safety data from the two studies were pooled for analysis, as predefined in the study protocols.
The evaluability criteria for efficacy analysis were predefined in the protocol as; any patient who received at least 2 cycles of therapy and one radiological evaluation.
The stage I safety analysis population was predefined in the protocol.
The hormone receptor status was close to significance, with the comparison of effects of treatments in the receptor-positive subgroup being predefined in the protocol.
As outlined by the CONSORT statement, reporting on subgroup effects in trials should only be done when the subgroup to be tested is predefined in the protocol, and the number of subgroups to be tested should be limited to the absolute minimum.
The types and clustering of complications were predefined in the study protocol, as described in Additional file 1. Pre-defined postoperative complications for each patient (see Additional file 1) were recorded for up to 28 days after surgery from the patient record and by visiting patients on the ward by the investigators.
The analysis approach was predefined in the study protocol.
