Box 24.

Exemplars on reporting item 17 elements

Example 1. Bayesian RAR; change in randomisation probabilities across arms throughout the trial; randomisation updates were made after every patient Giles et al. [67] present a table of changes in allocation probabilities used to create Fig. 3 by treatment group including allocated treatment and primary outcome response for each participant. Example 2. Inferentially seamless phase 2/3 AD; stage 1 treatment selection results Barnes et al. [141] clearly presented the results that led to the interim selection of the two indacaterol drug doses to progress to stage 2 of the study; 150 μg (the lowest dose that exceeded both pre-specified treatment selection criteria) and 300 μg (the next highest dose that met the same criteria). The interim difference in treatment effect compared to placebo with uncertainty per group for the two adaptation outcomes are displayed in Figs. 1 and 2 of the paper. Example 3. 2-stage GSD; stage 1 dose selection results “At the interim analysis planned after at least 1969 patients had been randomized and reached day 7 follow-up in each group [181], the otamixaban dose for stage 2 of the trial was selected as described in eFigure 1 in the Supplement. At that time, the rates of the primary efficacy outcome in the higher-dose otamixaban group was xx (4.7%) (the one selected to go forward) and was xx (5.6%) in the UFH-pluseptifibatide group (adjusted RR, 0.848; 95% CI, 0.662–1.087) but the lower-dose group fulfilled the pre-specified criteria for futility with a RR of more than 1 (primary efficacy outcome, xx (6.3%); RR, 1.130; 95% CI, 0.906–1.408) and was discontinued.” [144] xx are the corresponding number of participants with primary response that should have been stated. Example 4. Adapted from Khalil et al [143]; sequential-step AD. See Table 6