Analysis population for efficacy analysis and adverse outcome analysis12 19 22
| Analysis population | Definition |
|---|---|
| ITT | All randomised patients are included in efficacy analysis and adverse outcome analysis |
| mITT | All randomised patients, except a defined patient group, are included in efficacy analysis and adverse outcome analysis |
| As observed (AO) | Only patients who complete the trial are included in efficacy analysis and adverse outcome analysis |
| Per protocol (PP) | Patients who adhered to terms of eligibility, interventions and outcome assessment prespecified in the protocol are included in efficacy analysis and adverse outcome analysis |
| Other | None of the aforementioned categories fits the analysis population |
| Unclear | It is unclear which analysis is applied |
ITT, intention to treat; mITT, modified intention to treat.