Table 6 Original and revised sample size substantiation

Outcome

Relapses at 24 months after end of treatment

‘Unfavourable’ events at 24  months after end of treatment (MITT^a)

‘Unfavourable’ events 24  months after end of treatment (PP^b)

Events in control arm (%)

5%

20%

14%

1-sided significance level

2.5%

2.5%

2.5%

Power

80%

80%

80%

Non-inferiority margin δ

3%

6%

6%

Patients overall (n)

1,656

1,394

1,050

Adjustment for LTFU^c

20%

15% ^d

27% ^d

Patients after adjustment for LTFU (n)^d

2,070

1,640

1,438