Sentence examples for based on interim safety-data from inspiring English sources

48 In a phase III study of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy, the docetaxel dose was reduced from 100to7575 mg/m based on interim safety-data monitoring which identified a significantly higher toxic death rate in the chemotherapy arm of the study.

In particular, equipoise provides flawed ethical guidance for placebo-controlled trials and for decisions to terminate trials early based on interim data relating to benefit.

Because the DMC recommended early discontinuation of the study drug based on interim data, thereby decreasing the study's statistical power, additional study conclusions are limited.

However, according to Novo Nordisk, it seems that the US Food and Drug Administration has accepted a resubmitted marketing authorization application based on interim analysis of data from the DEVOTE study.

In February 2011, based on interim data as of October 2010 from 219 patients, the DMC recommended that all patients discontinue study treatment.

Based on interim results the independent Safety Monitoring and Advisory Board may decide to use the same adjudication procedure for other outcomes of interest too.

In the majority of cases, recommendations were made based on interim analysis in the interest of participant safety and it is reassuring that there was only a small proportion of trials where extended use of interim analysis or recommendations made by the DMC had the potential to introduce bias.

Whilst it is widely accepted that the primary role of the DMC is to protect participant safety, several other roles of the DMC have been suggested, including recommending protocol amendments based on interim analysis [ 5].

No treatment change was made based on interim PET scan results.

The primary efficacy analysis was based on the safety data set and was considered confirmatory.

Probiotic supplementation in pregnancy is considered safe based on the limited safety data available [ 20].