Table 5 Definition of population analysis sets
Analysis population | TXA group | Standard care group |
|---|---|---|
Intention to treat (“as randomized”) | Patients randomized to TXA group: • Including all protocol deviations | Patients randomized to standard care group: • Including all protocol deviations |
As treated (“actual treatment”) | Patients who received TXA (at least one dose), regardless of allocated treatment at randomization: • Including patients who received TXA as described according to protocol • Including patients who received TXA not following protocol (protocol deviation) • Including patients with other protocol deviations | Patients who did not receive TXA, regardless of allocated treatment at randomization: • Including patients who received standard care as described according to protocol • Including patients who received standard care not following protocol (protocol deviation) • Including patients with other protocol deviations |
Per protocol | Patients randomized to TXA group who received TXA (at least one dose): • Including patients who received TXA as described according to protocol • Including patients who received TXA not following protocol (protocol deviation) • Including patients with other protocol deviations | Patients randomized to standard care group who did not receive TXA: • Including patients who received standard care as described according to protocol • Including patients who received standard care not following protocol (protocol deviation) • Including patients with other protocol deviations |