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