Table 5.
Administrative interim analysis of the completeness of laboratory data (flow cytometry) for each visit relative to the number of enrolled patients feasible for 'per protocol’ analysis
| Groups | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | |
|---|---|---|---|---|---|---|
|
Overall n = 56 |
Complete data n |
32 |
38 |
44 |
44 |
25 |
| (% of 'per protocol’ population) |
(57) |
(68) |
(79) |
(79) |
(45) |
|
|
SCI T4 and above n = 28 |
Complete data n |
17 |
20 |
22 |
22 |
16 |
| (% of 'per protocol’ population) |
(61) |
(71) |
(79) |
(79) |
(57) |
|
|
SCI T5 and below n = 11 |
Complete data n |
6 |
6 |
8 |
10 |
5 |
| (% of 'per protocol’ population) |
(55) |
(55) |
(73) |
(91) |
(45) |
|
| Control group n = 17 | Complete data n |
9 |
12 |
14 |
12 |
4 |
| (% of 'per protocol’ population) | (53) | (71) | (82) | (71) | (24) |
Legend: The completeness of the main laboratory data was calculated for the three groups relative to the number of enrolled patients feasible for 'per protocol’ analysis. The sample size calculation takes a 50% rate of drop out or missing values into account. Considering the drop out rate < 10% at the current stage of the trial, a 60% rate of data completeness is acceptable. Critical rates of overall completeness are observed at visit 1 and visit 5 and relate mainly to the control group and to patients with neurological level T5 or below.