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. 2021 Oct 9;22:686. doi: 10.1186/s13063-021-05644-4

Table 7.

Description of other intercurrent events

Question
Number of trials with ≥ 1 other intercurrent event 10
Total number of other intercurrent events 15
Type of other intercurrent events
 Change to assigned treatment 4
 Use of non-trial treatment 10
 No embryos to transfer in an IVF trial 1
Planned strategy to handle other intercurrent events (n = 15)
 Stated 0/15 (0%)
 Inferable 12/15 (80%)
 Not inferable 3/15 (20%)
Reason inferable (n = 12)
 Analysis by ITT, inferred as treatment policy 12/12 (100%)
Reason not inferable (n = 3)
 Unclear how intercurrent events will be handled in the analysis 1/3 (33%)
 Participants with intercurrent events excluded, but unclear whether the intention is to target hypothetical or principal stratum strategy 1/3 (33%)
 Unclear which strategy intended analysis corresponds toa 1/3 (33%)

aActual dose of concomitant treatment given in each arm to be included as a covariate in regression model; unclear what intended treatment strategy this approach corresponds to