For analysis of binary or time-to-event data from multicentre trials using generalized mixed and frailty models, interpretation of centre heterogeneity can present challenges because random effects are linked to the outcome via nonlinear functions [ 40].
Using the principles and concepts developed in the present study, we are currently analysing the marker and skeletal event data from these trials, to further assess the role of markers in prediction of skeletal complications and determining its value in routine clinical practice.
Using data from hypertension outcome trials of at least 2-years duration and at least 100 patients, they reported trial-level regression models of the odds ratio of cardiovascular mortality and all cardiovascular events versus systolic blood pressure difference.
We encourage complete transparency of the data from clinical trials, particularly adverse events and patient dropout.
In addition, we calculated risk difference (RD), a measure of absolute effect that is both sensitive to between-trial differences in absolute event rates and inclusive of data from all trials, even those without reported events in either treatment arm.
For the safety analysis, we also included adverse events data from trials comparing any treatment regimen containing pyronaridine with regimens not containing pyronaridine.
The linear decision analytical model used in this study used health-care costs according to standard clinical practice from a variety of sources and relied on adverse event data from individual clinical trials that may not be fully comparable or reflective of adverse events in daily clinical practice.
After considering adverse event data from five large trials including predominantly OA patients, this CEA found that, over a 6-month treatment duration, celecoxib is more cost-effective than ns-NSAIDs, with and without PPI co-therapy, for treating Saudi Arabian OA patients aged ≥65 years.
Only data from trials after the learning trial was considered.
MVA85A was safe in subjects with HIV infection, with an adverse-event profile comparable with historical data from previous trials in HIV-uninfected subjects.
