Table 3.
Number of patients (in complete cohorts of 5) | Stop the trial for superiority if there are these many TMA events (inclusive) | Continue the trial if there are these many TMA events (inclusive) | Stop the trial for inferiority if there are these many TMA events (inclusive) |
5 | Never stop for superiority with these many patients | 0–1 | 2–5 |
10 or 15 | Never stop for superiority with these many patients | 0–2 | 3–15 |
20 | Never stop for superiority with these many patients | 0–3 | 4–20 |
25 or 30 | Never stop for superiority with these many patients | 0–4 (the trial always stops at 30 patients, which is the maximum) | 5–30 |