Table 1 Characteristics of the studies included in the review
Excluded from statistical analysis (N = 57) | Included in statistical analysis (N = 58) | Total (N = 115) | ||||
|---|---|---|---|---|---|---|
N | % | N | % | N | % | |
Phase | ||||||
I–II | 1 | 2 | 0 | 0 | 1 | 1 |
II | 19 | 33 | 19 | 33 | 38 | 33 |
II–III | 1 | 2 | 1 | 2 | 2 | 2 |
III | 36 | 63 | 38 | 65 | 74 | 64 |
Type of study—centre | ||||||
Multicentre | 43 | 75 | 57 | 98 | 100 | 87 |
Single centre | 14 | 25 | 1 | 2 | 15 | 13 |
Blinding | ||||||
Yes | 10 | 18 | 22 | 38 | 32 | 28 |
No | 47 | 82 | 36 | 62 | 83 | 72 |
Primary Endpoint | ||||||
OS | 32 | 56 | 24 | 41 | 56 | 49 |
PFS | 20 | 35 | 32 | 55 | 52 | 45 |
TTF | 1 | 2 | 0 | 0 | 1 | 1 |
TTP | 4 | 7 | 2 | 4 | 6 | 5 |
Proportionality assessed | ||||||
Yes | 2a | 4 | 2 | 3 | 4 | 3 |
No | 55 | 96 | 56 | 97 | 111 | 97 |
Sample size calculation | ||||||
Number of events reported | 25 | 44 | 45 | 78 | 70 | 61 |
Only number of patients reported | 23 | 40 | 9 | 15 | 32 | 28 |
Not provided | 9 | 16 | 4 | 7 | 13 | 11 |
Reached >95% of target events | ||||||
Yes | 14 | 82 | 26 | 81 | 40 | 82 |
No | 3 | 18 | 6 | 19 | 9 | 18 |
Number of patients analysed | ||||||
Median | 302 | 379 | 332 | |||
IQR | 154–440 | 175–772 | 168–595 | |||
Minimum–Maximum | 48–1725 | 60–1433 | 48–1725 | |||
