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Table 5 Description of handling of intercurrent events for the primary estimand

From: Estimands in published protocols of randomised trials: urgent improvement needed

Question*

Trials—n/N (%)

Non-adherence/discontinuation

 Applicable

50/50 (100%)

 Stated

0 (0%)

 Inferable

34 (68%)

 Not inferable

16 (32%)

Treatment switching

 Applicable

3/50 (6%)

 Stated

0/3 (0%)

 Inferable

3/3 (100%)

 Not inferable

0/3 (0%)

Mortality

 Applicable

20/50 (40%)

 Stated

0/20 (0%)

 Inferable

4/20 (20%)

 Not inferable

16/20 (80%)

Other intercurrent events

 Applicable

10/50 (20%)

 All stated

0/10 (0%)

 All inferable

7/10 (70%)

 Not all inferable

3/10 (30%)

  1. *Non-adherence/discontinuation is defined as applicable for all trials. Mortality was defined as applicable if it was listed as an outcome (or component of an outcome), or the protocol indicated some patients may die. Treatment switching and other intercurrent events were assumed to be not applicable (i.e. not expected in the trial) unless they were mentioned as expected in the protocol